CAPOX + Bevacizumab + Tislelizumab Treating PD-L1 CPS < 5 Locally Advanced or Metastatic GEA
NCT ID: NCT05299476
Last Updated: 2025-03-18
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
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
32 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-04-25
Study Completion Date
2025-01-20
Brief Summary
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his study was a single-arm, open, single-center Phase ii clinical trial to observe and evaluate the efficacy and safety of CAPOX+ bevacizumab + tislelizumab in first-line treatment of ADVANCED gastroesophageal adenocarcinoma with CPS \< 5.
This study targeted advanced gastric cancer patients who could not undergo radical treatment, who had not received systemic therapy before, or who had recurrence and metastasis more than 6 months after the end of adjuvant therapy.
The 6-month progression-free survival (PFS) rate will be used as the primary outcome indicator, and approximately 30 subjects will be enrolled.
Subject will receive CAPOX+ bevacizumab + tislelizumab continuously for a treatment cycle of 3 weeks after fully informed and signing informed consent, oxaliplatin will be stopped after 4-8 cycles, and other drugs will continue to be used until the treatment interruption event specified in the plan occurs. Post-treatment follow-up for safety and survival will continue after completion of treatment, and follow-up for tumor progression will also be conducted after completion of treatment for subjects who have not finished treatment for a cause of disease progression/death.
After the subjects were enrolled in the study, safety visits were conducted for each treatment cycle D1 before medication. Imaging will be performed every 2 cycles from the first year of treatment to assess efficacy, and every 3 cycles after 1 year until treatment ends, informed consent is withdrawn, or death.
This study targeted advanced gastric cancer patients who could not undergo radical treatment, who had not received systemic therapy before, or who had recurrence and metastasis more than 6 months after the end of adjuvant therapy.
The 6-month progression-free survival (PFS) rate will be used as the primary outcome indicator, and approximately 30 subjects will be enrolled.
Subject will receive CAPOX+ bevacizumab + tislelizumab continuously for a treatment cycle of 3 weeks after fully informed and signing informed consent, oxaliplatin will be stopped after 4-8 cycles, and other drugs will continue to be used until the treatment interruption event specified in the plan occurs. Post-treatment follow-up for safety and survival will continue after completion of treatment, and follow-up for tumor progression will also be conducted after completion of treatment for subjects who have not finished treatment for a cause of disease progression/death.
After the subjects were enrolled in the study, safety visits were conducted for each treatment cycle D1 before medication. Imaging will be performed every 2 cycles from the first year of treatment to assess efficacy, and every 3 cycles after 1 year until treatment ends, informed consent is withdrawn, or death.
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Detailed Description
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Conditions
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Advanced Gastroesophageal Adenocarcinoma
First-line Therapy
PDL1 CPS < 5
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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CAPOX combined with bevacizumab and Tislelizumab
Group Type
EXPERIMENTAL
CAPOX combined with bevacizumab and Tislelizumab
Intervention Type
DRUG
Oxaliplatin: intravenous infusion, 130mg/m2, infusion for more than 3h, every 3 weeks for a cycle, infusion 4-8 cycles; Capecitabine: oral administration, 2g/m2, 2 times, 14 days, 7 days rest, every 3 weeks for a cycle; Bevacizumab was administered intravenously (without prophylaxis) at 7.5mg/kg. The first infusion was 90min, the second infusion was 60min, and each infusion was 30 min. The drug was administered once every 3 weeks, and the longest cumulative duration was 2 years.
Tislelizumab is administered intravenously (without prophylaxis) at a fixed dose of 200mg. Each infusion was 30 min (no less than 20 min, no more than 60 min), and the drug was given once every 3 weeks for a cycle, with the longest cumulative duration of 2 years.
Interventions
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CAPOX combined with bevacizumab and Tislelizumab
Oxaliplatin: intravenous infusion, 130mg/m2, infusion for more than 3h, every 3 weeks for a cycle, infusion 4-8 cycles; Capecitabine: oral administration, 2g/m2, 2 times, 14 days, 7 days rest, every 3 weeks for a cycle; Bevacizumab was administered intravenously (without prophylaxis) at 7.5mg/kg. The first infusion was 90min, the second infusion was 60min, and each infusion was 30 min. The drug was administered once every 3 weeks, and the longest cumulative duration was 2 years.
Tislelizumab is administered intravenously (without prophylaxis) at a fixed dose of 200mg. Each infusion was 30 min (no less than 20 min, no more than 60 min), and the drug was given once every 3 weeks for a cycle, with the longest cumulative duration of 2 years.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* At the same time, patients voluntarily participated in the study and signed informed consent.
* Either male or female, aged 18 or older.
* Patients diagnosed by pathological or cytological diagnosis of gastric cancer (GC), gastroesophageal junction carcinoma (GEJ) or esophageal adenocarcinoma had evidence of local advanced lesions or metastases that could not be surgically resected, and were mostly adenocarcinoma confirmed by histological examination.
* Anyway, she has no previous systemic therapy; Or had received neoadjuvant/adjuvant chemotherapy but experienced disease progression or recurrence 6 months after the end of treatment;
* PDL-1 CPS \< 5, HER2 negative;
* Anyway, ECOG scores 0-1 on PS.Estimated survival ≥3 months;
* Anyway, their vital organs function according to the following rules:
1. Hemoglobin (HGB) ≥90g/L;
2. Neutrophil count (ANC) ≥1.5×109/L;
3. Platelet count (PLT) ≥80×109/L;
4. ALT and AST≤2.5×ULN;ALT and AST≤5×ULN for liver metastasis;
5. Total bilirubin (TBIL) ≤1.5 times normal upper limit (ULN);
6. Serum Cr≤1×ULN, endogenous creatinine clearance rate \> 50ml/min (Cockcroft-Gault formula);
7. Urinary protein \< (++), or 24-hour urinary protein \< 1.0g;
* Lent blood functions normally, without active bleeding or thrombotic disease:
1. INR≤1.5×ULN;
2. Partial thrombin time APTT≤1.5×ULN;
3. Prothrombin time PT≤1.5×ULN;
* Women of reproductive age had to undergo a pregnancy test (serum or urine) which was negative within 7 days of enrollment, and volunteer to use an appropriate method of contraception during the observation period and for 12 weeks after the last study drug was given. For men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and for 12 weeks after the last administration of the study drug;
* Anyway, people who comply are expected to be able to follow up on therapeutic outcomes and adverse reactions as required by the regimen.
* Either male or female, aged 18 or older.
* Patients diagnosed by pathological or cytological diagnosis of gastric cancer (GC), gastroesophageal junction carcinoma (GEJ) or esophageal adenocarcinoma had evidence of local advanced lesions or metastases that could not be surgically resected, and were mostly adenocarcinoma confirmed by histological examination.
* Anyway, she has no previous systemic therapy; Or had received neoadjuvant/adjuvant chemotherapy but experienced disease progression or recurrence 6 months after the end of treatment;
* PDL-1 CPS \< 5, HER2 negative;
* Anyway, ECOG scores 0-1 on PS.Estimated survival ≥3 months;
* Anyway, their vital organs function according to the following rules:
1. Hemoglobin (HGB) ≥90g/L;
2. Neutrophil count (ANC) ≥1.5×109/L;
3. Platelet count (PLT) ≥80×109/L;
4. ALT and AST≤2.5×ULN;ALT and AST≤5×ULN for liver metastasis;
5. Total bilirubin (TBIL) ≤1.5 times normal upper limit (ULN);
6. Serum Cr≤1×ULN, endogenous creatinine clearance rate \> 50ml/min (Cockcroft-Gault formula);
7. Urinary protein \< (++), or 24-hour urinary protein \< 1.0g;
* Lent blood functions normally, without active bleeding or thrombotic disease:
1. INR≤1.5×ULN;
2. Partial thrombin time APTT≤1.5×ULN;
3. Prothrombin time PT≤1.5×ULN;
* Women of reproductive age had to undergo a pregnancy test (serum or urine) which was negative within 7 days of enrollment, and volunteer to use an appropriate method of contraception during the observation period and for 12 weeks after the last study drug was given. For men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and for 12 weeks after the last administration of the study drug;
* Anyway, people who comply are expected to be able to follow up on therapeutic outcomes and adverse reactions as required by the regimen.
Exclusion Criteria
* Five years before first use of the study drug has been diagnosed as other malignant tumor, the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or except breast cancer.
* Known allergy to oxaliplatin, PD-1 mab, bevacizumab or pharmaceutical excipients;Or severe allergic reactions to other monoclonal antibodies;
* Chauvinist has any active autoimmune disease or a history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis,vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy); Patients with complete remission of childhood asthma without intervention or vitiligo as adults may be included, but not those requiring medical intervention with bronchodilators;
* HBV DNA\>500 IU/ mL (or 2000 copies /ml), HCV RNA\>103 copies /ml, HBsAg+ and anti-HCV antibody positive;
* Lent has a history of HIV infection;
* Accuser spends 14 days prior to first using a study drug, regardless of nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10 mg/ day of prednisone or an equivalent pharmacophysiological dose of another corticosteroid);
* A live attenuated vaccine was administered either four weeks before the first dose or during the study period;
* History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation is known；
* Hypertension that cannot be controlled even with standard treatment (systolic blood pressure ≥160mmHg/ diastolic blood pressure ≥100mmHg);
* Either having poorly controlled cardiac clinical symptoms or disease, such as :(1) NYHA grade 2 or higher heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, or (4) clinically significant supracventricular or ventricular arrhythmias requiring treatment or intervention;
* Patients at risk of serious bleeding, including but not limited to severe bleeding (bleeding \> 30 ml within 3 months), were evaluated by a physician who agreed to spend time on an endoscopic evaluation, which was subject to endoscopic evaluation.
* Either a thromboembolic event (including a stroke event and/or a transient ischemic attack) occurs within 6 months;
* Participates in another clinical trial, or participates in any other drug clinical study within four weeks, or at least five half-lives since the last study drug was taken;
* At the same time, participants in the Study underwent anti-tumor therapy including chemotherapy, radiotherapy and immunotherapy within 4 weeks prior to drug administration.
* At the same time, participants received palliative radiotherapy for bone metastasis within 2 weeks prior to the beginning of drug administration. Radiation therapy for other sites within the first 4 weeks;
* Regardless, toxicity from previous anti-tumor therapy does not return to CTCAE \[version 5.0\] level 0-1, as shown in the following.Except: a. hair loss;B. Pigmentation;C. Long-term toxicity caused by radiotherapy could not be recovered according to the judgment of researchers;
* Other conditions that the investigator deems inappropriate for inclusion;
* Known allergy to oxaliplatin, PD-1 mab, bevacizumab or pharmaceutical excipients;Or severe allergic reactions to other monoclonal antibodies;
* Chauvinist has any active autoimmune disease or a history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis,vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy); Patients with complete remission of childhood asthma without intervention or vitiligo as adults may be included, but not those requiring medical intervention with bronchodilators;
* HBV DNA\>500 IU/ mL (or 2000 copies /ml), HCV RNA\>103 copies /ml, HBsAg+ and anti-HCV antibody positive;
* Lent has a history of HIV infection;
* Accuser spends 14 days prior to first using a study drug, regardless of nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10 mg/ day of prednisone or an equivalent pharmacophysiological dose of another corticosteroid);
* A live attenuated vaccine was administered either four weeks before the first dose or during the study period;
* History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation is known；
* Hypertension that cannot be controlled even with standard treatment (systolic blood pressure ≥160mmHg/ diastolic blood pressure ≥100mmHg);
* Either having poorly controlled cardiac clinical symptoms or disease, such as :(1) NYHA grade 2 or higher heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, or (4) clinically significant supracventricular or ventricular arrhythmias requiring treatment or intervention;
* Patients at risk of serious bleeding, including but not limited to severe bleeding (bleeding \> 30 ml within 3 months), were evaluated by a physician who agreed to spend time on an endoscopic evaluation, which was subject to endoscopic evaluation.
* Either a thromboembolic event (including a stroke event and/or a transient ischemic attack) occurs within 6 months;
* Participates in another clinical trial, or participates in any other drug clinical study within four weeks, or at least five half-lives since the last study drug was taken;
* At the same time, participants in the Study underwent anti-tumor therapy including chemotherapy, radiotherapy and immunotherapy within 4 weeks prior to drug administration.
* At the same time, participants received palliative radiotherapy for bone metastasis within 2 weeks prior to the beginning of drug administration. Radiation therapy for other sites within the first 4 weeks;
* Regardless, toxicity from previous anti-tumor therapy does not return to CTCAE \[version 5.0\] level 0-1, as shown in the following.Except: a. hair loss;B. Pigmentation;C. Long-term toxicity caused by radiotherapy could not be recovered according to the judgment of researchers;
* Other conditions that the investigator deems inappropriate for inclusion;
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Chinese PLA General Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Dai, Guanghai
Director, Department of Oncology, PLA General Hospital
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Chinese PLA General Hospital
Beijing, , China
Site Status
Countries
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China
References
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Related Links
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http://clinicaltrials.gov/ct2/show/NCT03777657.
Related Info
Other Identifiers
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S2021-642-01
Identifier Type: -
Identifier Source: org_study_id
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NCT02563054
COMPLETED
PHASE3
Optimizing the Strategy for Preoperative Chemotherapy in Locally Advanced Gastric/Gastroesophageal Cancer
NCT02725424
COMPLETED
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
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.
NCT05111626
ACTIVE_NOT_RECRUITING
PHASE3
Phase III Study to Compare Perioperative Chemotherapy of Oxaliplatin Combined With S-1(SOX) Versus SOX or Oxaliplatin With Capecitabine (XELOX) as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma With D2 Dissection
NCT01534546
UNKNOWN
PHASE3
A Study to Evaluate the Efficacy and Safety of Trastuzumab in Combination With Capecitabine and Oxaliplatin as First-line Chemotherapy for Inoperable, Locally Advanced or Recurrent and/or Metastatic Gastric Cancer
NCT01364493
COMPLETED
PHASE2
M108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.
NCT06177041
RECRUITING
PHASE3
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
NCT03777657
COMPLETED
PHASE3
Tislelizumab Combined with SOX Regimen in the Treatment of Locally Advanced Gastric Cancer/gastroesophageal Junction Adenocarcinoma
NCT06764251
NOT_YET_RECRUITING
PHASE2