NCT03802591
Completed
Phase 3
A Multi-Center, Double-Blind, Randomized, Phase III Study of CS1001 in Combination With CAPOX Chemotherapy Compared to Placebo in Combination With CAPOX Chemotherapy in Subjects With Unresectable Locally Advanced or Metastatic GC or GEJ Adenocarcinoma
Overview
- Phase
- Phase 3
- Intervention
- CS1001 monoclonal antibody
- Conditions
- Gastric Adenocarcinoma
- Sponsor
- CStone Pharmaceuticals
- Enrollment
- 479
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS) evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a phase III, multi-Center, randomized, placebo-controlled trial to investigate the efficacy and safety of CS1001 in combination with Oxaliplatin and Capecitabine (CAPOX) chemotherapy in first-line subjects with unresectable locally advanced or metastatic gastric adenocarcinoma (GC) or gastro-esophageal junction (GEJ) adenocarcinoma.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years but ≤ 75 years
- •Being able to follow the protocol requirements as per investigator's evaluation.
- •Provide written informed consent before any protocol-related procedure (that is not a part of subject's routine care) is carried out.
- •Unresectable locally advanced or metastatic gastric carcinoma (GC) or gastro-esophageal junction (GEJ) carcinoma, and have histologically confirmed predominant adenocarcinoma.
- •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.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or
- •Expected survival ≥ 3 months.
- •Subject must not have received systemic treatment (including HER2 inhibitor) for advanced or metastatic gastric carcinoma.
- •Subject must provide tumor tissue samples for biomarker analysis in order to determine the expression of PD-L
- •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).
Exclusion Criteria
- •Known HER-2 positivity.
- •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.
- •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).
- •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.
- •Known positive human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
- •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.
- •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.).
- •Subjects with conditions that in the investigator's opinion are not suitable for participating in this trial.
Arms & Interventions
CS1001 monoclonal antibody
in combination with Oxaliplatin and Capecitabine
Intervention: CS1001 monoclonal antibody
CS1001 monoclonal antibody
in combination with Oxaliplatin and Capecitabine
Intervention: Oxaliplatin
CS1001 monoclonal antibody
in combination with Oxaliplatin and Capecitabine
Intervention: Capecitabine
CS1001 placebo
in combination with Oxaliplatin and Capecitabine
Intervention: CS1001 placebo
CS1001 placebo
in combination with Oxaliplatin and Capecitabine
Intervention: Oxaliplatin
CS1001 placebo
in combination with Oxaliplatin and Capecitabine
Intervention: Capecitabine
Outcomes
Primary Outcomes
Progression-free survival (PFS) evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to approximately 27 months
Overall survival (OS)
Time Frame: from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months
Secondary Outcomes
- Duration of response (DOR) (evaluated by investigators according to RECIST v1.1)(from date of first documented objective response until first documented sign of disease progression or death due to any causes, whichever comes first, assessed up to approximately 27 months)
- Progression-free survival (PFS) evaluated by Blinded Independent Central Review Committee (BICR) according to RECIST v1.1(from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to approximately 27 months)
- Objective response rate (ORR) evaluated by investigators according to RECIST v1.1(from the first dose of treatment until the best response, assessed up to 27 months)
- Overall survival rate at 12 months and 24 months(from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months)
- Evaluate the safety of CS1001 in combination with CAPOX chemotherapy compared to placebo in combination with CAPOX chemotherapy(from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months)
Study Sites (1)
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