A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer
- Conditions
- Gastric or Gastroesophageal Junction Cancer
- Interventions
- Drug: SHR-1701、CAPOXDrug: Placebo、CAPOX
- Registration Number
- NCT04950322
- Lead Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Brief Summary
This study is a randomized, Double-Blind, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of SHR1701 combined with chemotherapy in the treatment of Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer. For Part 1 study，the tolerability of SHR-1701 will be evaluated and determine the recommended dose for Part 2.For Part 2 study, all enrolled patients will be randomized to 2 groups and continuously treated until the end criteria of treatment was met.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 737
- Pathologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ)adenocarcinoma.
- HER2 overexpression or amplification negative.
- Female or male, 18 years of age or above.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
- Patients who are willing and able to provide the signed informed consent form, willing and able to comply with all the scheduled visits, study treatment, laboratory tests, and other study procedures.
- Squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer.
- Presence of inadequately treated CNS metastases, or uncontrolled or symptomatic active CNS metastases ，leptomeningeal disease, and/or rapid progression.
- Presence of uncontrolled pleural effusion or ascites despite puncture drainage within 14 days prior to randomization.
- More than 20% weight loss within 2 months prior to randomization.
- Diagnosed with other malignant tumors within 5 years prior to enrollment.
- Presence of any active, known or suspected autoimmune disease.
- Prior treatment with TGF-β inhibitor, anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, anti-CTLA-4 antibodies, or other drugs/antibodies.
- Severe, unhealed, or dehisced wounds and active ulcers or untreated fractures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group A SHR-1701、CAPOX - Treatment group B Placebo、CAPOX -
- Primary Outcome Measures
Name Time Method OS in all subjects in part 2 study up to 3 years Overall survival (OS)
AEs and SAEs in part 1 study up to 2 years The number and proportion of subjects with dose limiting toxicity. The safety endpoints, including incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Overall survival in subjects with PD-L1 CPS ≥ 5 in part 2 study up to 3 years
- Secondary Outcome Measures
Name Time Method OS in part 1 study up to 3 years Overall survival (OS)
PFS in part 1 study up to 2 years Progression free survival (PFS) as assessed by the investigator per RECIST 1.1
DoR in part 1 study up to 2 years Duration of response (DoR) as assessed by the investigator per RECIST 1.1
DoR in part2 study up to 2 years DoR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1
ORR in part 1 study up to 2 years Objective response rate (ORR) as assessed by the investigator per RECIST 1.1
ORR in part 2 study up to 2 years ORR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator per RECIST 1.1
EORTC QLQ-STO22 score up to 2 years EQ-5D-5L score up to 2 years DCR in part 1 study up to 2 years Disease control rate (DCR) as assessed by the investigator per RECIST 1.1
PFS in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator as per RECIST 1.1 up to 2 years DoR in part 2 study up to 2 years DoR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator per RECIST 1.1
PFS in part 2 study up to 3 years PFS in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1
DCR in part 2 study up to 2 years DCR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator per RECIST 1.1
AEs and SAEs in part 2 study up to 2 years Safety endpoints, including incidence and severity of AEs and SAEs as per NCI-CTCAE v5.0 criteria
EORTC QLQ-C30 score up to 2 years
Trial Locations
- Locations (1)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China