A Clinical Study to Evaluate HLX10 Monotherapy for the Treatment of MSI-H or dMMR Solid Tumors That Failed to Respond to Standard Therapy
NCT ID: NCT03941574
Last Updated: 2022-10-28
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
PHASE2
Total Enrollment
108 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-07-15
Study Completion Date
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
It is a single-arm, open-label, multicenter, phase II clinical study to evaluate the clinical efficacy and safety of HLX10 monotherapy for the treatment of patients with unresectable or metastatic MSI-H or dMMR solid tumors who have progressed or intolerable after standard therapy.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. The enrolled subjects will receive an intravenous infusion of HLX10 (3 mg/kg) once every 2 weeks until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent or other reasons as specified in the protocol, or up to the longest treatment duration-2 years (52 dosing periods) (whichever occurs earlier).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Trial Comparing HLX10 With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
NCT03958890
Esophageal Squamous Cell Carcinoma
UNKNOWN
PHASE3
A Clinical Study to Evaluate Efficacy and Safety of HLX10 Combined With Albumin-Bound Paclitaxel in Patients With Advanced Cervical Cancer Who Have Progressive Disease or Intolerable Toxicity After First-Line Standard Chemotherapy
NCT04150575
Cervical Cancer
UNKNOWN
PHASE2
A Clinical Study of HLX10 Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer
NCT04139135
Gastric Cancer
UNKNOWN
PHASE3
HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
NCT04486651
Stomach Cancer
UNKNOWN
PHASE3
HLX07+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer
NCT05246982
Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
UNKNOWN
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
MSI-H Solid Malignant Tumor
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.
HLX10
Group Type
EXPERIMENTAL
HLX10
Intervention Type
DRUG
HLX10 developed by our company is sterile intravenous injection, with specification of 100 mg/10 mL/bottle. The main ingredient is 10.0 mg/mL of recombinant humanized anti-PD-1 monoclonal antibody. The excipients include 0.95 mg/mL citric acid (citric acid monohydrate), 4.56 mg/mL sodium citrate (sodium citrate dihydrate), 3.0 mg/mL sodium chloride, 30.0 mg/mL mannitol and 0.20 mg/mL polysorbate 80 (tween 80), with pH of 5.5.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HLX10
HLX10 developed by our company is sterile intravenous injection, with specification of 100 mg/10 mL/bottle. The main ingredient is 10.0 mg/mL of recombinant humanized anti-PD-1 monoclonal antibody. The excipients include 0.95 mg/mL citric acid (citric acid monohydrate), 4.56 mg/mL sodium citrate (sodium citrate dihydrate), 3.0 mg/mL sodium chloride, 30.0 mg/mL mannitol and 0.20 mg/mL polysorbate 80 (tween 80), with pH of 5.5.
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects who meet all of the following criteria are allowed to be enrolled into this study:
* Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
* Age ≥ 18 years and ≤ 75 years when ICF is signed;
* Patients with unresectable or metastatic MSI-H or dMMR malignant solid tumors which are histopathologically or/and cytologically confirmed by the central laboratory or study sites;
* Patients who have disease progression or intolerable reactions after the currently available standard anti-cancer treatment previously received;
* The interval between the end of previous systemic anti-tumor treatment and the first dosing of if this study must be ≥ 2 weeks. In addition, treatment-related AEs recover to NCI-CTCAE v4.03 ≤ grade 1 (excluding grade 2 alopecia).
* There is at least one measurable lesion assessed by IRRC according to the requirements of RECIST version 1.1 (Appendix 1).
Note: measurable lesions cannot be selected from the previous radiotherapy sites. If the target lesion of the previous radiotherapy sites is the only one available lesion, the investigator is required to provide imaging data before and after significant progression of such lesion.
• Subjects must provide tumor tissues and blood samples for the determination of MSI, tumor mutational burden (TMB), PD-L1 expression level (if the test results of the above parameters by the central laboratory specified by this study are available, the subjects are allowed not to receive repeated tests).
Note: it is recommended to provide formalin fixed tumor tissue samples collected from non-radiotherapy sites within 6 months prior to the first dosing of investigational product, paraffin embedded tumor samples (preferred), or formalin fixed paraffin embedded tumor samples or unstained newly sliced serial sections (glass slides). Moreover, the corresponding pathological reports of the above samples must also be provided. Freshly collected samples, excision, core needle biopsy, resection, incision, punching or forceps biopsies are within the acceptable range (newly-obtained tissues preferred). The aspiration samples (i.e., lack of complete tissue structure and only cell suspension and/or cell smears are provided), brushing samples, cell precipitation samples from pleural or peritoneal effusion are not acceptable. The requirements for tissue samples are provided in laboratory operating manual in detail.
* ECOG performance status score (Appendix II) of 0 or 1 within 7 days before the first dose of invetigational product;
* Life expectancy ≥12 weeks;
* Negative HBsAg; patients with positive HBsAg or HBcAb test results can be enrolled only if Hepatitis B virus (HBV) DNA test results are negative.
11.Negative HCV antibody; patients with positive HCV antibody or HCV-RNA test results can be enrolled only if ALT and AST are CTCAE v4.03 ≤ grade 1 (i.e., ≤ 3×ULN); subjects concurrently infected with hepatitis B and hepatitis C are excluded.
* Normal function of main organs, and the following criteria are met (within the 14 days before the first injection of investigational product, patients have not received the treatment with blood transfusion, albumin, recombinant human thrombopoietin or colony stimulating factor (CSF)):
* Female subjects must meet the following criteria:
① Menopause (defined as no menstruation for at least one year, and no other confirmed reasons other than menopause), or② Received surgical sterilization (ovariectomy and/or hysterectomy), or③ Subjects who are able to bear or father a child must meet the following criteria:
* Serum pregnancy test must be negative within 7 days before the first dosing, and
* Agree to use contraceptive methods with an annual failure rate of \< 1% or maintain sexual abstinence (avoid heterosexual intercourse) (from the signing of informed consent form to at least 120 days after the last dose of investigational product) (contraceptive methods with an annual failure rate of \< 1% include bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives which may inhibit ovulation, hormone-releasing intrauterine device and copper intrauterine device), and
* Breast-feeding is not allowed.
* Male subjects should meet the criteria below: agree to maintain sexual abstinence (avoid heterosexual intercourse) or use contraceptive methods, with requirements detailed below: if the partners of male subjects have childbearing potential or become pregnant, male subjects must maintain sexual abstinence or use condoms to prevent drug exposure to embryos during administration period of investigational product and within at least 120 days after after the last dose of investigational product. The reliability of sexual abstinence should be evaluated based on the duration of clinical studies, preference of the subjects and daily life style. Regular sexual abstinence (e.g., calendar days, ovulation period, basal body temperature or post-ovulation period contraceptive methods) and coitus interruptus are disqualified contraceptive methods.
* Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
* Age ≥ 18 years and ≤ 75 years when ICF is signed;
* Patients with unresectable or metastatic MSI-H or dMMR malignant solid tumors which are histopathologically or/and cytologically confirmed by the central laboratory or study sites;
* Patients who have disease progression or intolerable reactions after the currently available standard anti-cancer treatment previously received;
* The interval between the end of previous systemic anti-tumor treatment and the first dosing of if this study must be ≥ 2 weeks. In addition, treatment-related AEs recover to NCI-CTCAE v4.03 ≤ grade 1 (excluding grade 2 alopecia).
* There is at least one measurable lesion assessed by IRRC according to the requirements of RECIST version 1.1 (Appendix 1).
Note: measurable lesions cannot be selected from the previous radiotherapy sites. If the target lesion of the previous radiotherapy sites is the only one available lesion, the investigator is required to provide imaging data before and after significant progression of such lesion.
• Subjects must provide tumor tissues and blood samples for the determination of MSI, tumor mutational burden (TMB), PD-L1 expression level (if the test results of the above parameters by the central laboratory specified by this study are available, the subjects are allowed not to receive repeated tests).
Note: it is recommended to provide formalin fixed tumor tissue samples collected from non-radiotherapy sites within 6 months prior to the first dosing of investigational product, paraffin embedded tumor samples (preferred), or formalin fixed paraffin embedded tumor samples or unstained newly sliced serial sections (glass slides). Moreover, the corresponding pathological reports of the above samples must also be provided. Freshly collected samples, excision, core needle biopsy, resection, incision, punching or forceps biopsies are within the acceptable range (newly-obtained tissues preferred). The aspiration samples (i.e., lack of complete tissue structure and only cell suspension and/or cell smears are provided), brushing samples, cell precipitation samples from pleural or peritoneal effusion are not acceptable. The requirements for tissue samples are provided in laboratory operating manual in detail.
* ECOG performance status score (Appendix II) of 0 or 1 within 7 days before the first dose of invetigational product;
* Life expectancy ≥12 weeks;
* Negative HBsAg; patients with positive HBsAg or HBcAb test results can be enrolled only if Hepatitis B virus (HBV) DNA test results are negative.
11.Negative HCV antibody; patients with positive HCV antibody or HCV-RNA test results can be enrolled only if ALT and AST are CTCAE v4.03 ≤ grade 1 (i.e., ≤ 3×ULN); subjects concurrently infected with hepatitis B and hepatitis C are excluded.
* Normal function of main organs, and the following criteria are met (within the 14 days before the first injection of investigational product, patients have not received the treatment with blood transfusion, albumin, recombinant human thrombopoietin or colony stimulating factor (CSF)):
* Female subjects must meet the following criteria:
① Menopause (defined as no menstruation for at least one year, and no other confirmed reasons other than menopause), or② Received surgical sterilization (ovariectomy and/or hysterectomy), or③ Subjects who are able to bear or father a child must meet the following criteria:
* Serum pregnancy test must be negative within 7 days before the first dosing, and
* Agree to use contraceptive methods with an annual failure rate of \< 1% or maintain sexual abstinence (avoid heterosexual intercourse) (from the signing of informed consent form to at least 120 days after the last dose of investigational product) (contraceptive methods with an annual failure rate of \< 1% include bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives which may inhibit ovulation, hormone-releasing intrauterine device and copper intrauterine device), and
* Breast-feeding is not allowed.
* Male subjects should meet the criteria below: agree to maintain sexual abstinence (avoid heterosexual intercourse) or use contraceptive methods, with requirements detailed below: if the partners of male subjects have childbearing potential or become pregnant, male subjects must maintain sexual abstinence or use condoms to prevent drug exposure to embryos during administration period of investigational product and within at least 120 days after after the last dose of investigational product. The reliability of sexual abstinence should be evaluated based on the duration of clinical studies, preference of the subjects and daily life style. Regular sexual abstinence (e.g., calendar days, ovulation period, basal body temperature or post-ovulation period contraceptive methods) and coitus interruptus are disqualified contraceptive methods.
Exclusion Criteria
* Subjects who meet any of the following criteria are not allowed to be enrolled in this study:
* Subjects who plan to undergo or previously underwent organ or bone marrow transplantation.
* Uncontrollable pleural effusion, pericardial effusion or ascites after appropriate intervention measures.
* Subjects with known or screening test-confirmed active central nervous system (CNS) metastasis and/or carcinomatous meningitis; However, the following subjects are allowed to be enrolled: 1. subjects with asymptomatic brain metastasis (i.e. without progressive central nervous system symptoms caused by brain metastatic lesions, without the requirement of corticosteroids treatment, and lesion size ≤1.5cm) are allowed to participate in this study, however, it is necessary to perform regular brain imaging tests for disease sites. 2. subjects with brain metastasis after treatment, and brain metastatic lesions are stable for at least 1 month, without evidence of new or expanded brain metastasis, and steroids are discontinued 3 days prior to the first dose of the investigational product. Stable brain metastasis in this definition should be confirmed before the first dose of the investigational product.
* Subjects with spinal cord compression which cannot be radically treated through surgery and/or radiotherapy, or subjects previously diagnosed with spinal cord compression with no post-treatment clinical evidence showing stable disease ≥ 1 week before the first dose of the investigational product.
* Imaging test results show definit tumor invasion of thoracic great vessels.
* Occurrence of myocardial ischemia above grade Ⅱ , or myocardial infarction, unstable angina pectoris, inadequately controlled arrhythmia (including QTc interval ≥ 450 ms for males, and ≥ 470 ms for females) within half a year before the first dose of the investigational product (QTc interval is calculated based on Fridericia formula).
* Grade Ⅲ or Ⅳ cardiac dysfunction based on New York Heart Association (NYHA) Functional Classification (appendix Ⅲ) or echocardiography test showing left ventricular ejection fraction (LVEF) \< 50%.
* Presence of peripheral neuropathy with CTCAE v4.03 ≥ grade 2.
* Infection with human immunodeficiency virus (HIV).
* Presence of active pulmonary tuberculosis.
* Previously or currently suffering from interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, seriously injured lung function and other conditions which may interfere with the detection and treatment of suspected drug-related pulmonary toxicity.
* Presence of know active or suspected autoimmune diseases; Patients who have stable status and require no treatment with systemic immunosuppressive therapies are allowed to be enrolled.
* Treatment with live vaccines within 28 days before the first administration of investigational product.
* Subjects requiring treatment with systemic corticosteroids (\> 10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressive therapies within 14 days before the first administration of investigational product or during the study period; However, the following conditions are allowed to be enrolled: in the event of no active autoimmune diseases, inhalation or topical use of steroids or adrenaline alternative treatment of effective dose of prednisone ≤ 10 mg/day are allowed.
* Presence of any active infection requiring systemic anti-infection treatment within 14 days before the first administration of investigational product.
* Subjects who have received major surgery within 28 days before the first administration of investigational product, by "major surgery", it meant that the patient needs at least three weeks to recover following the surgery before being able to receive the study treatment. Enrollment through tumor puncture or lymph node biopsy is allowed.
* Received radical radiotherapy within 3 months before the first administration of investigational product.
Note: palliative radiotherapies for bones or superficial lesions are acceptable. The course of treatment should be in accordance with the local standard and has ended 14 days before the first administration. Radiotherapy covering more than 30% of the bone marrow area is not allowed within 28 days prior to the first dose.
* Other anti-tumor treatments such as chemotherapy, targeted therapy or radiotherapy (excluding palliative radiotherapy) may be received during the study period.
* Previously received treatment with any T cells costimulation or immune checkpoint, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other targeted T cells drugs.
* Subjects are participating in other clinical studies, or the time interval between the initiation of treatment planned in this study and end of investigational product treatment in the previous clinical study is less than 14 days.
* Known serious hypersensitivity history to any monoclonal antibody or the excipients of investigational product.
* Pregnant or lactating women.
* Known history of abuse of psychotropic drugs or drug addiction; Subjects who have stopped drinking are allowed to be enrolled.
* The subjects have other factors which may cause premature termination of this study at the discretion of the investigators.
* Subjects who plan to undergo or previously underwent organ or bone marrow transplantation.
* Uncontrollable pleural effusion, pericardial effusion or ascites after appropriate intervention measures.
* Subjects with known or screening test-confirmed active central nervous system (CNS) metastasis and/or carcinomatous meningitis; However, the following subjects are allowed to be enrolled: 1. subjects with asymptomatic brain metastasis (i.e. without progressive central nervous system symptoms caused by brain metastatic lesions, without the requirement of corticosteroids treatment, and lesion size ≤1.5cm) are allowed to participate in this study, however, it is necessary to perform regular brain imaging tests for disease sites. 2. subjects with brain metastasis after treatment, and brain metastatic lesions are stable for at least 1 month, without evidence of new or expanded brain metastasis, and steroids are discontinued 3 days prior to the first dose of the investigational product. Stable brain metastasis in this definition should be confirmed before the first dose of the investigational product.
* Subjects with spinal cord compression which cannot be radically treated through surgery and/or radiotherapy, or subjects previously diagnosed with spinal cord compression with no post-treatment clinical evidence showing stable disease ≥ 1 week before the first dose of the investigational product.
* Imaging test results show definit tumor invasion of thoracic great vessels.
* Occurrence of myocardial ischemia above grade Ⅱ , or myocardial infarction, unstable angina pectoris, inadequately controlled arrhythmia (including QTc interval ≥ 450 ms for males, and ≥ 470 ms for females) within half a year before the first dose of the investigational product (QTc interval is calculated based on Fridericia formula).
* Grade Ⅲ or Ⅳ cardiac dysfunction based on New York Heart Association (NYHA) Functional Classification (appendix Ⅲ) or echocardiography test showing left ventricular ejection fraction (LVEF) \< 50%.
* Presence of peripheral neuropathy with CTCAE v4.03 ≥ grade 2.
* Infection with human immunodeficiency virus (HIV).
* Presence of active pulmonary tuberculosis.
* Previously or currently suffering from interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, seriously injured lung function and other conditions which may interfere with the detection and treatment of suspected drug-related pulmonary toxicity.
* Presence of know active or suspected autoimmune diseases; Patients who have stable status and require no treatment with systemic immunosuppressive therapies are allowed to be enrolled.
* Treatment with live vaccines within 28 days before the first administration of investigational product.
* Subjects requiring treatment with systemic corticosteroids (\> 10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressive therapies within 14 days before the first administration of investigational product or during the study period; However, the following conditions are allowed to be enrolled: in the event of no active autoimmune diseases, inhalation or topical use of steroids or adrenaline alternative treatment of effective dose of prednisone ≤ 10 mg/day are allowed.
* Presence of any active infection requiring systemic anti-infection treatment within 14 days before the first administration of investigational product.
* Subjects who have received major surgery within 28 days before the first administration of investigational product, by "major surgery", it meant that the patient needs at least three weeks to recover following the surgery before being able to receive the study treatment. Enrollment through tumor puncture or lymph node biopsy is allowed.
* Received radical radiotherapy within 3 months before the first administration of investigational product.
Note: palliative radiotherapies for bones or superficial lesions are acceptable. The course of treatment should be in accordance with the local standard and has ended 14 days before the first administration. Radiotherapy covering more than 30% of the bone marrow area is not allowed within 28 days prior to the first dose.
* Other anti-tumor treatments such as chemotherapy, targeted therapy or radiotherapy (excluding palliative radiotherapy) may be received during the study period.
* Previously received treatment with any T cells costimulation or immune checkpoint, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other targeted T cells drugs.
* Subjects are participating in other clinical studies, or the time interval between the initiation of treatment planned in this study and end of investigational product treatment in the previous clinical study is less than 14 days.
* Known serious hypersensitivity history to any monoclonal antibody or the excipients of investigational product.
* Pregnant or lactating women.
* Known history of abuse of psychotropic drugs or drug addiction; Subjects who have stopped drinking are allowed to be enrolled.
* The subjects have other factors which may cause premature termination of this study at the discretion of the investigators.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Henlius Biotech
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Site Status
RECRUITING
Peking University International Hospital
Beijing, Beijing Municipality, China
Site Status
RECRUITING
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Site Status
RECRUITING
the 900th Hospital of Joint Logistic Support Force
Fuzhou, Fujian, China
Site Status
RECRUITING
Zhongnan Hospital of Wuhan University
Wuhan, Fujian, China
Site Status
RECRUITING
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Site Status
RECRUITING
First People's Hospital of Fushan
Fushan, Guangdong, China
Site Status
RECRUITING
The First Affiliated Hospital and Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Site Status
RECRUITING
The First Affiliated Hospital (School of Clinical Medicine), Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Site Status
RECRUITING
Affiliated Cancer Hospital & Institute, Guangzhou Medical University
Guangzhou, Guangdong, China
Site Status
RECRUITING
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Site Status
RECRUITING
Affiliated Hospital of Guangdong Medical University
Zhenjiang, Guangdong, China
Site Status
RECRUITING
Zhongshan city People's Hospital
Zhongshan, Guangdong, China
Site Status
RECRUITING
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, Guangdong, China
Site Status
RECRUITING
The People's Hospital of Guangxi Zhuangzu Autonomous Region
Nanning, Guangxi, China
Site Status
RECRUITING
Fourth Hospital of Hebei Medical University,
Shijiazhuang, Hebei, China
Site Status
RECRUITING
Harbin Medical University Cancer Hospital,
Harbin, Heilongjiang, China
Site Status
RECRUITING
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Site Status
RECRUITING
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Site Status
RECRUITING
The Third Xiangya Hospital, Central South University
Changsha, Hunan, China
Site Status
RECRUITING
Hunan Cancer Hospital
Changsha, Hunan, China
Site Status
RECRUITING
Qinhuai Medical District, General Hospital of the eastern theater of the Chinese people's Liberation Army
Nanjing, Jiangsu, China
Site Status
RECRUITING
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Site Status
RECRUITING
Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Site Status
RECRUITING
Qilu Hospital of Shandong University
Jinan, Shandong, China
Site Status
RECRUITING
Shandong Cancer Hospital
Jinan, Shandong, China
Site Status
RECRUITING
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Site Status
RECRUITING
Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China
Chengdu, Sichuan, China
Site Status
RECRUITING
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Site Status
RECRUITING
Tianjin Medical University Cancer Institue and Hospital
Tianjin, Tianjin Municipality, China
Site Status
RECRUITING
Yunnan Cancer Hospital/The Third Affiliated Hospital of Kunming Medical University/Yunnan Cancer Center
Kunming, Yunnan, China
Site Status
RECRUITING
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Site Status
RECRUITING
Taizhou first people's Hospital
Taizhou, Zhejiang, 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.
Zhendong Chen
Role: primary
Jun Liang
Role: primary
Tao Zhang
Role: primary
Xi Chen
Role: primary
Fuxiang Zhou
Role: primary
Huangyang Ye
Role: primary
Wei Wang
Role: primary
Shirong Cai
Role: primary
Xicheng Wang
Role: primary
Chuan Jin
Role: primary
Yanhong Deng
Role: primary
Zhong Xie
Role: primary
Jianjun Xiao
Role: primary
Hongyu Zhang
Role: primary
Kehe Chen
Role: primary
Da Jiang
Role: primary
Yuxian Bai
Role: primary
Qingxia Fan
Role: primary
Xianglin Yuan
Role: primary
Peiguo Cao
Role: primary
Xianli Yin
Role: primary
Yang Zhang
Role: primary
Jingdong Zhang
Role: primary
Xiuwen Wang
Role: primary
Changzheng Li
Role: primary
Jin Li
Role: primary
Yongdong Jin
Role: primary
Qing Zhu
Role: primary
Xiubao Ren
Role: primary
Yunfeng Li
Role: primary
Haijun Zhong
Role: primary
Lili Chen
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Shukui Qin, Jin Li, Haijun Zhong, et al. Efficacy and safety of HLX10, a novel anti-PD-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors: A single-arm, multicenter, phase 2 study. Journal of Clinical Oncology 2021 39:15_suppl, 2566-2566
Reference Type
RESULT
Qin S, Li J, Zhong H, Jin C, Chen L, Yuan X, Fan Q, Chen K, Cao P, Xiao J, Jiang D, Zhang T, Zhang H, Wang X, Wang W, Han L, Wang Q, Zhu J; Serplulimab-MSI-H Investigators. Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial. Br J Cancer. 2022 Dec;127(12):2241-2248. doi: 10.1038/s41416-022-02001-3. Epub 2022 Oct 19.
Reference Type
RESULT
Related Links
Access external resources that provide additional context or updates about the study.
https://www.nature.com/articles/s41416-022-02001-3
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HLX10-010-MSI201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma
NCT05918094
RECRUITING
PHASE3
PD-1 Monoclonal Antibody Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma
NCT04341857
UNKNOWN
PHASE2
Pegliposomal Doxorubicin and 5-fluorouracil as Second Line Therapy for Metastatic Gastric Cancer
NCT04358341
UNKNOWN
PHASE2
Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
NCT07115485
RECRUITING
PHASE2
Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer
NCT04908813
ACTIVE_NOT_RECRUITING
PHASE2
Short-course Radiotherapy Combined With Neoadjuvant Chemotherapy and PD-1 Inhibitor in the Treatment of Locally Advanced Gastric Adenocarcinoma
NCT05563012
RECRUITING
PHASE2
Study of HLX10, Trastuzumab and Chemotherapy in First-line Treatment of HER2-positive Recurrent/Metastatic Gastric Cancer
NCT05311189
UNKNOWN
PHASE2
Phase II Study of Liposomal Irinotecan for Advanced Refractory Gastric Cancer
NCT06437678
NOT_YET_RECRUITING
PHASE2
Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer
NCT03745170
COMPLETED
PHASE3
Assessing Iparomlimab and Tuvonralimab in Recurrent or Metastatic MSI-H/dMMR Gastric Cancer
NCT07127822
NOT_YET_RECRUITING
PHASE2
Axitinib Plus Toripalimab as Second-line Treatment in Hepatobiliary Malignant Tumors
NCT04010071
UNKNOWN
PHASE2
Nab-paclitaxel Plus PD-1 Inhibitor Versus Nab-paclitaxel As Second-line Treatment in Advanced Gastric Cancer
NCT04294784
TERMINATED
PHASE2
A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.
NCT00436241
COMPLETED
PHASE2
A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma
NCT00980382
COMPLETED
PHASE1/PHASE2
First- Line Treatment With Durvalumab Plus XELOX Chemotherapy in Advanced Gastrointestinal Neuroendocrine Carcinoma
NCT06070740
RECRUITING
PHASE2
Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients
NCT06383559
RECRUITING
PHASE2
Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer
NCT00639327
COMPLETED
PHASE2/PHASE3
Sintilimab Combined With LDRT for Neoadjuvant Treatment of Locally Advanced dMMR/MSI-H Gastric Cancer
NCT06426654
NOT_YET_RECRUITING
PHASE1/PHASE2
Perioperative Therapy for HER2-negative Hepatoid Adenocarcinoma of Stomach
NCT07178340
RECRUITING
PHASE2
Comparing the Efficacy of Sintilimab Plus Nab-POF Regimen, Sintilimab Plus XELOX Chemotherapy, and Lenvatinib, Sintilimab Plus XELOX Chemotherapy in the Treatment of HER2-negative, Metastatic Gastric Cancer
NCT06748508
NOT_YET_RECRUITING
PHASE2
First Line Chemotherapy for Advanced Cancer
NCT01980810
TERMINATED
PHASE2
Combination of QLS31905, QL2107 and Chemotherapy as First-line Therapy in CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
NCT06942767
NOT_YET_RECRUITING
PHASE2
A Study to Assess the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Administered Intravenously (IV) as a Single Agent or in Combination With Chemotherapy in Chinese Participants With Locally Advanced or Metastatic Solid Tumors
NCT02825940
COMPLETED
PHASE1
Safety and Efficacy of Glumetinib Combined With Docetaxel for Injection (Albumin-bound) in Patients With Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and Other Solid Tumors
NCT06947291
RECRUITING
PHASE2
The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer
NCT02395640
COMPLETED
PHASE3