Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer
NCT ID: NCT05640609
Last Updated: 2023-05-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
PHASE1/PHASE2
Total Enrollment
57 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-03-10
Study Completion Date
2026-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The median survival time of first-line chemotherapy for advanced gastric cancer is about one year, and the treatment is still facing the bottleneck. This is a one-arm, open and prospective phase II clinical study. Recruit patients who have been diagnosed with advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction and have not received systematic treatment.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CAPOX Plus Sintilimab and Bevacizumab Biosimilar (IBI305) for Neoadjuvant Treatment of Locally Advanced Gastric Cancer
NCT06667050
Gastric Adenocarcinoma
ACTIVE_NOT_RECRUITING
PHASE2
CAPOX + Bevacizumab + Tislelizumab Treating PD-L1 CPS < 5 Locally Advanced or Metastatic GEA
NCT05299476
Advanced Gastroesophageal Adenocarcinoma
First-line Therapy
PDL1 CPS < 5
COMPLETED
PHASE2
Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma
NCT00780494
Stomach Cancer
Gastric (Stomach) Cancer
Neoplasm of Cardioesophageal Junction
+1 more
COMPLETED
PHASE2
Cadonilimab Combined With CapeOX Regimen in Perioperative Treatment of Resectable Locally Advanced Gastric Cancer
NCT05974059
Locally Advanced Unresectable Gastric Adenocarcinoma
UNKNOWN
PHASE2
Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or Limited Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
NCT04263870
Gastroesophageal Junction Adenocarcinoma
Stomach Adenocarcinoma
Locally Advanced Unresectable Gastric Adenocarcinoma
+1 more
UNKNOWN
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The median survival time of first-line chemotherapy for advanced gastric cancer is about one year, and the treatment is still facing the bottleneck. Bevacizumab is an anti-vascular endothelial growth factor (VEGF) targeted therapy drug. It is doubtful whether the low dose of bevacizumab in gastric cancer patients leads to poor curative effect. Now the treatment of advanced gastric cancer has come to the era of immunotherapy. The chemotherapy regimen of daclizumab combined with CAPEOX has been proved to be effective in clinical studies. No clinical study has confirmed the safety and efficacy of CAPEOX regimen combined with sintilimab and bevacizumab.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Stomach Neoplasm
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Capeox regimen combined with Sintilimab and Bevacizumab
Capeox regimen combined with Sintilimab and Bevacizumab
Group Type
EXPERIMENTAL
Capeox regimen combined with Sintilimab and Bevacizumab
Intervention Type
COMBINATION_PRODUCT
Stage Ib：Oxaliplatin +Capecitabine Tablets +Sintilimab +Bevacizumab Stage II：Bevacizumab (the dose determined in phase Ib clinical study)，the dosage of other drugs was the same as before
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Capeox regimen combined with Sintilimab and Bevacizumab
Stage Ib：Oxaliplatin +Capecitabine Tablets +Sintilimab +Bevacizumab Stage II：Bevacizumab (the dose determined in phase Ib clinical study)，the dosage of other drugs was the same as before
Intervention Type
COMBINATION_PRODUCT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Histological or cytological diagnosis confirmed adenocarcinoma of stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma)
2. Imaging and surgical evaluation of unresectable recurrent or metastatic patients
3. The expected survival time was more than 3 months
4. The age is between 18 and 70 years old, both male and female
5. No systematic treatment has been given to patients with advanced or metastatic gastric and esophagogastric junction adenocarcinoma.If the patients who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy and chemotherapy), the last treatment must be completed at least 6 months before randomization, and there is no recurrence or disease progression at the time of treatment.Palliative radiotherapy was allowed, but it must be completed at least 2 weeks before the first study treatment.Subjects were allowed to receive anti-tumor traditional Chinese medicine preparations in the past, but they must be discontinued at least 2 weeks before randomization
6. Eastern Cooperative Oncology Group(ECoG) - 1 physical status
7. At least one lesion can be evaluated according to RECIST 1.1 criteria
8. It can provide pathological tissues or fresh pathological tissues that are filed within 6 months after the signature of informed consent for screening, and can obtain the test results. For the slices filed within 6 months before randomization, it should be confirmed that no systematic treatment (including adjuvant / neoadjuvant therapy) has been received after obtaining the samples
9. The function of the main organs is normal, that is to say, it meets the following standards:
1. Blood routine examination (no blood transfusion within 14 days before screening)
2. Hemoglobin ≥ 90 g / L;
3. Absolute neutrophil count (ANC) ≥ 1.5×109/L;
4. Platelet count ≥ 75×109/L; Blood biochemical test (albumin was not used within 14 days before screening)
5. Albumin ≥ 28 g / L;
6. Total bilirubin ≤ 1.5×Upper limit of normal value (ULN);
7. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3×ULN; If there is liver metastasis, aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 5×ULN
8. Creatinine ≤ 1.5×ULN;Coagulation function:
9. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN;
10. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN
10. For sections filed in the first 6 months of randomization, it should be confirmed that no systematic treatment (including adjuvant / neoadjuvant therapy) has been received since sample acquisition
2. Imaging and surgical evaluation of unresectable recurrent or metastatic patients
3. The expected survival time was more than 3 months
4. The age is between 18 and 70 years old, both male and female
5. No systematic treatment has been given to patients with advanced or metastatic gastric and esophagogastric junction adenocarcinoma.If the patients who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy and chemotherapy), the last treatment must be completed at least 6 months before randomization, and there is no recurrence or disease progression at the time of treatment.Palliative radiotherapy was allowed, but it must be completed at least 2 weeks before the first study treatment.Subjects were allowed to receive anti-tumor traditional Chinese medicine preparations in the past, but they must be discontinued at least 2 weeks before randomization
6. Eastern Cooperative Oncology Group(ECoG) - 1 physical status
7. At least one lesion can be evaluated according to RECIST 1.1 criteria
8. It can provide pathological tissues or fresh pathological tissues that are filed within 6 months after the signature of informed consent for screening, and can obtain the test results. For the slices filed within 6 months before randomization, it should be confirmed that no systematic treatment (including adjuvant / neoadjuvant therapy) has been received after obtaining the samples
9. The function of the main organs is normal, that is to say, it meets the following standards:
1. Blood routine examination (no blood transfusion within 14 days before screening)
2. Hemoglobin ≥ 90 g / L;
3. Absolute neutrophil count (ANC) ≥ 1.5×109/L;
4. Platelet count ≥ 75×109/L; Blood biochemical test (albumin was not used within 14 days before screening)
5. Albumin ≥ 28 g / L;
6. Total bilirubin ≤ 1.5×Upper limit of normal value (ULN);
7. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3×ULN; If there is liver metastasis, aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 5×ULN
8. Creatinine ≤ 1.5×ULN;Coagulation function:
9. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN;
10. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN
10. For sections filed in the first 6 months of randomization, it should be confirmed that no systematic treatment (including adjuvant / neoadjuvant therapy) has been received since sample acquisition
Exclusion Criteria
12. Female subjects of childbearing age were required to conduct a serum pregnancy test within 3 days before the start of the study, and the results were negative, and they were willing to use a medically recognized high-efficiency contraceptive method (such as intrauterine device, contraceptive or condom) during the study period and within 3 months after the last administration of the study drug;For male subjects whose partners are women of childbearing age, they should be sterilized by surgery or agree to use effective contraceptive methods during the study and within 3 months after the last study administration
13. With my consent and signed the letter of understanding, I am willing and able to follow the planned visit, research treatment, laboratory examination and other test procedures
1. HER2 + (or HER2 +) is known to be positive
2. Gastric cancer known as squamous cell carcinoma, undifferentiated or other tissue types, or adenocarcinoma mixed with other tissue types
3. There are uncontrolled or symptomatic active central nervous system (CNS) metastases, which can be characterized by clinical symptoms, brain edema, spinal cord compression, cancer metastasis, malignant meningitis, leptomeningeal disease, and / or progressive growth.Patients with CNS metastases can be enrolled in the study if they are adequately treated and their psychiatric symptoms can return to baseline level at least 2 weeks before randomization (except for residual signs or symptoms related to CNS treatment).In addition, subjects were required to discontinue corticosteroids or receive prednisone (or equivalent other corticosteroids) at least 2 weeks before randomization, or to receive a stable or gradually reduced dose of prednisone (or equivalent) at least 2 weeks before randomization
4. There were hydrothorax and ascites which could not be controlled by puncture and drainage within 14 days before the random;Pericardial effusion with clinical symptoms or moderate or above
5. The weight of the subjects decreased by more than 20% in the first two months of randomization
6. The following treatments or drugs were received before randomization: a) major surgery was performed within 28 days before randomization (tissue biopsy and peripherally inserted central catheter operation peripherally inserted central venous catheter （PICC） for diagnosis are allowed; b) immunosuppressive drugs were used within 7 days before randomization,Does not include nasal and inhaled corticosteroids or physiological doses of systemic hormones (i.e. no more than 10 mg / D of nisone or other corticosteroids with equivalent physiologic doses);c) Live attenuated vaccine was administered within 28 days before randomization or within 60 days after the end of drug treatment;d) Antineoplastic therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biotherapy or tumor embolization) within 28 days before randomization
7. Any other malignant tumor was diagnosed within 3 years before entering the study, except basal cell carcinoma of skin or squamous or superficial bladder cancer, carcinoma in situ of cervix, intraductal carcinoma of breast and papillary thyroid carcinoma that can be treated locally and cured.
8. There is any active, known or suspected autoimmune disease.Subjects who were in a stable state and did not need systemic immunosuppressive therapy were allowed to be included, such as type I diabetes mellitus, hypothyroid diabetes mellitus requiring hormone replacement therapy only, and skin diseases without systemic treatment (e.g., vitiligo, psoriasis and alopecia)
9. Previously received anti-PD-1 / PD-L1 antibody, anti-CTLA-4 antibody or other drugs acting on T-cell co stimulation or examination cell co stimulation or checkpoint pathway
10. There were significant bleeding symptoms or bleeding tendency in 3 months before random;Gastrointestinal perforation and / or gastrointestinal fistula occurred within 6 months before randomization;Arteriovenous thrombosis events occurred in the first 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc
11. Major vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral artery thrombosis) within 6 months before the start of study treatment
12. Severe, unhealed or dehiscent wounds and active ulcers or untreated fractures
13. There were peripheral neuropathy \> 1 grade
14. If the symptoms of ileus (ileus) at the beginning of the study (with or without complete parenteral nutrition treatment) and symptoms of ileus were resolved at the time of initial diagnosis or complete parenteral nutrition treatment, or if the patient did not have the symptoms of ileus at the time of initial diagnosis / treatment, or had not received complete parenteral nutrition treatment,Patients may be admitted to the study
15. Interstitial lung disease, non infectious inflammation or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia, etc.)
16. Known allergy to the study drug or any of its excipients, or severe allergic reactions to other monoclonal antibodies
17. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS)
18. Untreated active hepatitis B was defined as HBV-DNA ≥ 500 IU / ml;Hepatitis C, defined as HCV-RNA higher than the detection limit of the analytical method;Or combined with hepatitis B and C co infection
19. In the first 6 months, the following conditions occurred: myocardial infarction, severe / unstable angina pectoris, New York Heart Association （NYHA ）grade 2 or above cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure
20. Hypertension was poorly controlled by drug therapy (systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg)
21. Systemic use of antibiotics for more than 7 days in 4 weeks before randomization, or fever of unknown origin \> 38.5 ° C during screening period / before first administration (fever due to tumor can be included in the group according to the judgment of the researcher)
22. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
23. Participated in any other drug clinical study within 4 weeks before randomization, or no more than 5 half-life from the last study
24. A history of psychotropic substance abuse or abuse is known
25. The presence of other laboratory abnormalities with severe physical or mental illness may increase the risk of participating in the study, or interfere with the results of the study and patients considered unsuitable for the study
13. With my consent and signed the letter of understanding, I am willing and able to follow the planned visit, research treatment, laboratory examination and other test procedures
1. HER2 + (or HER2 +) is known to be positive
2. Gastric cancer known as squamous cell carcinoma, undifferentiated or other tissue types, or adenocarcinoma mixed with other tissue types
3. There are uncontrolled or symptomatic active central nervous system (CNS) metastases, which can be characterized by clinical symptoms, brain edema, spinal cord compression, cancer metastasis, malignant meningitis, leptomeningeal disease, and / or progressive growth.Patients with CNS metastases can be enrolled in the study if they are adequately treated and their psychiatric symptoms can return to baseline level at least 2 weeks before randomization (except for residual signs or symptoms related to CNS treatment).In addition, subjects were required to discontinue corticosteroids or receive prednisone (or equivalent other corticosteroids) at least 2 weeks before randomization, or to receive a stable or gradually reduced dose of prednisone (or equivalent) at least 2 weeks before randomization
4. There were hydrothorax and ascites which could not be controlled by puncture and drainage within 14 days before the random;Pericardial effusion with clinical symptoms or moderate or above
5. The weight of the subjects decreased by more than 20% in the first two months of randomization
6. The following treatments or drugs were received before randomization: a) major surgery was performed within 28 days before randomization (tissue biopsy and peripherally inserted central catheter operation peripherally inserted central venous catheter （PICC） for diagnosis are allowed; b) immunosuppressive drugs were used within 7 days before randomization,Does not include nasal and inhaled corticosteroids or physiological doses of systemic hormones (i.e. no more than 10 mg / D of nisone or other corticosteroids with equivalent physiologic doses);c) Live attenuated vaccine was administered within 28 days before randomization or within 60 days after the end of drug treatment;d) Antineoplastic therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biotherapy or tumor embolization) within 28 days before randomization
7. Any other malignant tumor was diagnosed within 3 years before entering the study, except basal cell carcinoma of skin or squamous or superficial bladder cancer, carcinoma in situ of cervix, intraductal carcinoma of breast and papillary thyroid carcinoma that can be treated locally and cured.
8. There is any active, known or suspected autoimmune disease.Subjects who were in a stable state and did not need systemic immunosuppressive therapy were allowed to be included, such as type I diabetes mellitus, hypothyroid diabetes mellitus requiring hormone replacement therapy only, and skin diseases without systemic treatment (e.g., vitiligo, psoriasis and alopecia)
9. Previously received anti-PD-1 / PD-L1 antibody, anti-CTLA-4 antibody or other drugs acting on T-cell co stimulation or examination cell co stimulation or checkpoint pathway
10. There were significant bleeding symptoms or bleeding tendency in 3 months before random;Gastrointestinal perforation and / or gastrointestinal fistula occurred within 6 months before randomization;Arteriovenous thrombosis events occurred in the first 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc
11. Major vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral artery thrombosis) within 6 months before the start of study treatment
12. Severe, unhealed or dehiscent wounds and active ulcers or untreated fractures
13. There were peripheral neuropathy \> 1 grade
14. If the symptoms of ileus (ileus) at the beginning of the study (with or without complete parenteral nutrition treatment) and symptoms of ileus were resolved at the time of initial diagnosis or complete parenteral nutrition treatment, or if the patient did not have the symptoms of ileus at the time of initial diagnosis / treatment, or had not received complete parenteral nutrition treatment,Patients may be admitted to the study
15. Interstitial lung disease, non infectious inflammation or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia, etc.)
16. Known allergy to the study drug or any of its excipients, or severe allergic reactions to other monoclonal antibodies
17. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS)
18. Untreated active hepatitis B was defined as HBV-DNA ≥ 500 IU / ml;Hepatitis C, defined as HCV-RNA higher than the detection limit of the analytical method;Or combined with hepatitis B and C co infection
19. In the first 6 months, the following conditions occurred: myocardial infarction, severe / unstable angina pectoris, New York Heart Association （NYHA ）grade 2 or above cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure
20. Hypertension was poorly controlled by drug therapy (systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg)
21. Systemic use of antibiotics for more than 7 days in 4 weeks before randomization, or fever of unknown origin \> 38.5 ° C during screening period / before first administration (fever due to tumor can be included in the group according to the judgment of the researcher)
22. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
23. Participated in any other drug clinical study within 4 weeks before randomization, or no more than 5 half-life from the last study
24. A history of psychotropic substance abuse or abuse is known
25. The presence of other laboratory abnormalities with severe physical or mental illness may increase the risk of participating in the study, or interfere with the results of the study and patients considered unsuitable for the study
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
West China Hospital
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ming Liu
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Liu Ming, Professor
Role: STUDY_CHAIR
West China Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Liu Ming
Chengdu, , China
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
China
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.
Reference Type
BACKGROUND
Van Cutsem E, de Haas S, Kang YK, Ohtsu A, Tebbutt NC, Ming Xu J, Peng Yong W, Langer B, Delmar P, Scherer SJ, Shah MA. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a biomarker evaluation from the AVAGAST randomized phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2119-27. doi: 10.1200/JCO.2011.39.9824. Epub 2012 May 7.
Reference Type
BACKGROUND
Han K, Jin J, Maia M, Lowe J, Sersch MA, Allison DE. Lower exposure and faster clearance of bevacizumab in gastric cancer and the impact of patient variables: analysis of individual data from AVAGAST phase III trial. AAPS J. 2014 Sep;16(5):1056-63. doi: 10.1208/s12248-014-9631-6. Epub 2014 Jun 19.
Reference Type
BACKGROUND
Kang YK, Chen LT, Ryu MH, Oh DY, Oh SC, Chung HC, Lee KW, Omori T, Shitara K, Sakuramoto S, Chung IJ, Yamaguchi K, Kato K, Sym SJ, Kadowaki S, Tsuji K, Chen JS, Bai LY, Oh SY, Choda Y, Yasui H, Takeuchi K, Hirashima Y, Hagihara S, Boku N. Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):234-247. doi: 10.1016/S1470-2045(21)00692-6. Epub 2022 Jan 11.
Reference Type
BACKGROUND
Shitara K, Van Cutsem E, Bang YJ, Fuchs C, Wyrwicz L, Lee KW, Kudaba I, Garrido M, Chung HC, Lee J, Castro HR, Mansoor W, Braghiroli MI, Karaseva N, Caglevic C, Villanueva L, Goekkurt E, Satake H, Enzinger P, Alsina M, Benson A, Chao J, Ko AH, Wainberg ZA, Kher U, Shah S, Kang SP, Tabernero J. Efficacy and Safety of Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy Alone for Patients With First-line, Advanced Gastric Cancer: The KEYNOTE-062 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Oct 1;6(10):1571-1580. doi: 10.1001/jamaoncol.2020.3370.
Reference Type
BACKGROUND
Fukumura D, Kloepper J, Amoozgar Z, Duda DG, Jain RK. Enhancing cancer immunotherapy using antiangiogenics: opportunities and challenges. Nat Rev Clin Oncol. 2018 May;15(5):325-340. doi: 10.1038/nrclinonc.2018.29. Epub 2018 Mar 6.
Reference Type
BACKGROUND
Lee MS, Ryoo BY, Hsu CH, Numata K, Stein S, Verret W, Hack SP, Spahn J, Liu B, Abdullah H, Wang Y, He AR, Lee KH; GO30140 investigators. Atezolizumab with or without bevacizumab in unresectable hepatocellular carcinoma (GO30140): an open-label, multicentre, phase 1b study. Lancet Oncol. 2020 Jun;21(6):808-820. doi: 10.1016/S1470-2045(20)30156-X.
Reference Type
BACKGROUND
Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.
Reference Type
BACKGROUND
Ren Z, Xu J, Bai Y, Xu A, Cang S, Du C, Li Q, Lu Y, Chen Y, Guo Y, Chen Z, Liu B, Jia W, Wu J, Wang J, Shao G, Zhang B, Shan Y, Meng Z, Wu J, Gu S, Yang W, Liu C, Shi X, Gao Z, Yin T, Cui J, Huang M, Xing B, Mao Y, Teng G, Qin Y, Wang J, Xia F, Yin G, Yang Y, Chen M, Wang Y, Zhou H, Fan J; ORIENT-32 study group. Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study. Lancet Oncol. 2021 Jul;22(7):977-990. doi: 10.1016/S1470-2045(21)00252-7. Epub 2021 Jun 15.
Reference Type
BACKGROUND
Rini BI, Powles T, Atkins MB, Escudier B, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Lee JL, Hawkins R, Ravaud A, Alekseev B, Staehler M, Uemura M, De Giorgi U, Mellado B, Porta C, Melichar B, Gurney H, Bedke J, Choueiri TK, Parnis F, Khaznadar T, Thobhani A, Li S, Piault-Louis E, Frantz G, Huseni M, Schiff C, Green MC, Motzer RJ; IMmotion151 Study Group. Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial. Lancet. 2019 Jun 15;393(10189):2404-2415. doi: 10.1016/S0140-6736(19)30723-8. Epub 2019 May 9.
Reference Type
BACKGROUND
Socinski MA, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kelsch C, Lee A, Coleman S, Deng Y, Shen Y, Kowanetz M, Lopez-Chavez A, Sandler A, Reck M; IMpower150 Study Group. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med. 2018 Jun 14;378(24):2288-2301. doi: 10.1056/NEJMoa1716948. Epub 2018 Jun 4.
Reference Type
BACKGROUND
Sugawara S, Lee JS, Kang JH, Kim HR, Inui N, Hida T, Lee KH, Yoshida T, Tanaka H, Yang CT, Nishio M, Ohe Y, Tamura T, Yamamoto N, Yu CJ, Akamatsu H, Namba Y, Sumiyoshi N, Nakagawa K. Nivolumab with carboplatin, paclitaxel, and bevacizumab for first-line treatment of advanced nonsquamous non-small-cell lung cancer. Ann Oncol. 2021 Sep;32(9):1137-1147. doi: 10.1016/j.annonc.2021.06.004. Epub 2021 Jun 15.
Reference Type
BACKGROUND
Colombo N, Dubot C, Lorusso D, Caceres MV, Hasegawa K, Shapira-Frommer R, Tewari KS, Salman P, Hoyos Usta E, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Toker S, Li K, Keefe SM, Monk BJ; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435. Epub 2021 Sep 18.
Reference Type
BACKGROUND
Antoniotti C, Rossini D, Pietrantonio F, Catteau A, Salvatore L, Lonardi S, Boquet I, Tamberi S, Marmorino F, Moretto R, Ambrosini M, Tamburini E, Tortora G, Passardi A, Bergamo F, Kassambara A, Sbarrato T, Morano F, Ritorto G, Borelli B, Boccaccino A, Conca V, Giordano M, Ugolini C, Fieschi J, Papadopulos A, Massoue C, Aprile G, Antonuzzo L, Gelsomino F, Martinelli E, Pella N, Masi G, Fontanini G, Boni L, Galon J, Cremolini C; GONO Foundation Investigators. Upfront FOLFOXIRI plus bevacizumab with or without atezolizumab in the treatment of patients with metastatic colorectal cancer (AtezoTRIBE): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet Oncol. 2022 Jul;23(7):876-887. doi: 10.1016/S1470-2045(22)00274-1. Epub 2022 May 27.
Reference Type
BACKGROUND
Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
Reference Type
RESULT
Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, Dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-39. doi: 10.1016/S0140-6736(13)61719-5. Epub 2013 Oct 3.
Reference Type
RESULT
Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.
Reference Type
RESULT
Fuchs CS, Shitara K, Di Bartolomeo M, Lonardi S, Al-Batran SE, Van Cutsem E, Ilson DH, Alsina M, Chau I, Lacy J, Ducreux M, Mendez GA, Alavez AM, Takahari D, Mansoor W, Enzinger PC, Gorbounova V, Wainberg ZA, Hegewisch-Becker S, Ferry D, Lin J, Carlesi R, Das M, Shah MA; RAINFALL Study Group. Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):420-435. doi: 10.1016/S1470-2045(18)30791-5. Epub 2019 Feb 1.
Reference Type
RESULT
Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
Reference Type
RESULT
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
250260270
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer
NCT02038621
UNKNOWN
PHASE2
A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer
NCT02560974
COMPLETED
PHASE3
Pembrolizumab + Capecitabine／Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive
NCT04249739
ACTIVE_NOT_RECRUITING
PHASE2
Irinotecan, Cisplatin, and Bevacizumab in Treating Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
NCT00084604
COMPLETED
PHASE2
A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer
NCT02563054
COMPLETED
PHASE3
A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer
NCT00887822
COMPLETED
PHASE3
Cadonilimab Plus CapeOX as First-Line Treatment for Advanced GC/GEJC With High TMEscore
NCT06202716
NOT_YET_RECRUITING
PHASE2
Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced Gastric Cancer
NCT00669370
UNKNOWN
PHASE2
Oxaliplatin and S-1 or Oxaliplatin and Capecitabine in Treating Patients With Recurrent, Metastatic, or Unresectable Gastric Cancer
NCT00985556
UNKNOWN
PHASE2
Combination of Osemitamab (TST001), Pembrolizumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC/GEJ Adenocarcinoma
NCT06093425
NOT_YET_RECRUITING
PHASE3
The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer
NCT02395640
COMPLETED
PHASE3
Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer
NCT06349967
NOT_YET_RECRUITING
PHASE2
Safety and Efficacy of Systemic Chemotherapy Plus PD-1 Inhibitor in Combination With Bevacizumab in Gastric Cancer With Peritoneal Metastasis
NCT06487715
ENROLLING_BY_INVITATION
PHASE2
A Study of Bevacizumab in Combination With Capecitabine and Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer
NCT00548548
COMPLETED
PHASE3
MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric Cancer
NCT02007148
UNKNOWN
PHASE2
BC001 in Combination with Sintilimab and XELOX in the Treatment of HER-2 Negative Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.
NCT06773312
RECRUITING
PHASE1
Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma
NCT01757171
COMPLETED
PHASE2
Nivolumab Combined With SOX Used in the Perioperative Treatment
NCT05739045
RECRUITING
PHASE2
Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma
NCT01711242
COMPLETED
PHASE2
CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Locally Recurrent Colorectal Cancer
NCT06881537
RECRUITING
PHASE2
A Study of Pazopanib With CAPEOX in AGC Patients
NCT01130805
COMPLETED
PHASE2
Sintilimab in Combination With S-1/Oxaliplatin With Nab-paclitaxel Intraperitoneal Infusion for Untreated Advanced Gastric Cancer With Malignant Ascites
NCT06046963
UNKNOWN
PHASE2
Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer
NCT06329973
RECRUITING
PHASE1/PHASE2
Cabazitaxel in Asian Patients With Advanced Gastric Cancer Who Failed Prior Chemotherapy
NCT01497964
COMPLETED
PHASE1/PHASE2