A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-Esophageal Junction Adenocarcinoma
NCT ID: NCT03802591
Last Updated: 2023-11-29
Study Results
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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COMPLETED
PHASE3
479 participants
INTERVENTIONAL
2019-03-28
2023-09-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CS1001 monoclonal antibody
in combination with Oxaliplatin and Capecitabine
CS1001 monoclonal antibody
Participant will receive CS1001 monoclonal antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months
Oxaliplatin
Administered as an IV infusion on Day 1 Q3W
Capecitabine
Administered by oral, twice a day on Day 1 - Day 14 of each cycle.
CS1001 placebo
in combination with Oxaliplatin and Capecitabine
CS1001 placebo
Participant will receive CS1001 placebo antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months
Oxaliplatin
Administered as an IV infusion on Day 1 Q3W
Capecitabine
Administered by oral, twice a day on Day 1 - Day 14 of each cycle.
Interventions
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CS1001 monoclonal antibody
Participant will receive CS1001 monoclonal antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months
CS1001 placebo
Participant will receive CS1001 placebo antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months
Oxaliplatin
Administered as an IV infusion on Day 1 Q3W
Capecitabine
Administered by oral, twice a day on Day 1 - Day 14 of each cycle.
Eligibility Criteria
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Inclusion Criteria
2. Being able to follow the protocol requirements as per investigator's evaluation.
3. Provide written informed consent before any protocol-related procedure (that is not a part of subject's routine care) is carried out.
4. Unresectable locally advanced or metastatic gastric carcinoma (GC) or gastro-esophageal junction (GEJ) carcinoma, and have histologically confirmed predominant adenocarcinoma.
5. The subject may have at least a measurable lesion or an evaluable lesion, if not measurable; the investigator will carry out evaluation according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to randomization.
6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
7. Expected survival ≥ 3 months.
8. Subject must not have received systemic treatment (including HER2 inhibitor) for advanced or metastatic gastric carcinoma.
9. Subject must provide tumor tissue samples for biomarker analysis in order to determine the expression of PD-L1. According to central laboratory test, the PD-L1 expression is ≥ 5% in tumor tissue (including PD-L1 expression in tumor cells and tumor infiltrating immune cells).
10. Permitted prior treatment: Subjects with GC or GEJ carcinoma priorly treated with adjuvant or neoadjuvant therapy, who experience clinical progression of disease at least 6 months after last dose are allowed to be enrolled.
11. Subjects must have adequate organ function as assessed in the laboratory tests
12. Subjects with active hepatitis B or active hepatitis C must receive antiviral treatment for at least 14 days prior to the first dose of study treatment and pass the hepatitis B virus (HBV) DNA titer test (≤ 500 IU/mL or 2500 copies/mL) and hepatitis C virus (HCV) RNA test (≤ lower limit of detection) before being enrolled. The subject should be willing to continue effective anti-viral treatment during the study.
13. Female subject with childbearing potential must have negative serum pregnancy test result at screening, except for those with available sterilization operation record or post-menopausal subjects. Female subject with childbearing potential or male subjects and their partners must agree to take effective contraceptive measures from the day of signing ICF till at least 6 months after the last dosing of investigational product.
Exclusion Criteria
2. A known additional primary malignancy that occurred within 5 years prior to the first dose of investigational treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
3. Known primary central nerve system (CNS) tumor or meningeal metastasis, or unstable CNS metastasis (symptomatic within 4 weeks before first dose of investigational product, requiring corticosteroid treatment, or without radiologic evidence supporting stable status for over 4 weeks prior to the first dose of investigational product).
4. Any severe or uncontrolled systemic disease, for example diabetes mellitus or hypertension, that may increase the risk associated with participation or investigational product administration, or compromise subject's ability to receive investigational product, as per investigator's judgment.
5. Known positive human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
6. Has had prior chemotherapy, immune therapy, biological therapy (including cancer vaccine, cytokine therapy or growth factors to control cancer) used as systemic treatment for cancer, within 14 days before the first dose of investigational product.
7. Any prior treatment of antibody/drug that targets at T-cell coregulatory proteins or immune checkpoints pathways(including anti-PD-1, anti-PD-L1, anti-CTLA4, anti-TIM3, anti-LAG3 antibody, etc.).
8. Subjects with conditions that in the investigator's opinion are not suitable for participating in this trial.
18 Years
75 Years
ALL
No
Sponsors
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CStone Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Beijing Cancer Hospital
Beijing, , China
Countries
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References
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Zhang X, Wang J, Wang G, Zhang Y, Fan Q, Lu C, Hu C, Sun M, Wan Y, Sun S, Wang J, Zhang L, Shu Y, Luo J, Zhu D, Shen Z, Yao S, Shi Q, Yang J, Shen L; GEMSTONE-303 Investigators. First-Line Sugemalimab Plus Chemotherapy for Advanced Gastric Cancer: The GEMSTONE-303 Randomized Clinical Trial. JAMA. 2025 Apr 15;333(15):1305-1314. doi: 10.1001/jama.2024.28463.
Other Identifiers
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CS1001-303
Identifier Type: -
Identifier Source: org_study_id