Gastric or Gastroesophageal Junction Cancer
Conditions
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.
Interventions
DRUGSHR-1701、CAPOX
SHR-1701 with CAPOX (CAPOX:Oxaliplatin,Capecitabine)
DRUGPlacebo、CAPOX
Placebo with CAPOX (CAPOX:Oxaliplatin,Capecitabine)
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pathologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ)adenocarcinoma. 2. HER2 overexpression or amplification negative. 3. Female or male, 18 years of age or above. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. 5. 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.
Exclusion criteria
1. Squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer. 2. Presence of inadequately treated CNS metastases, or uncontrolled or symptomatic active CNS metastases ，leptomeningeal disease, and/or rapid progression. 3. Presence of uncontrolled pleural effusion or ascites despite puncture drainage within 14 days prior to randomization. 4. More than 20% weight loss within 2 months prior to randomization. 5. Diagnosed with other malignant tumors within 5 years prior to enrollment. 6. Presence of any active, known or suspected autoimmune disease. 7. 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. 8. Severe, unhealed, or dehisced wounds and active ulcers or untreated fractures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| OS in all subjects in part 2 study | up to 3 years | Overall survival (OS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DoR in part 1 study | up to 2 years | Duration of response (DoR) as assessed by the investigator per RECIST 1.1 |
| OS in part 1 study | up to 3 years | Overall survival (OS) |
| 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 |
| ORR in part 2 study | up to 2 years | ORR 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 BICR 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 |
| 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 |
| 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 | — |
| EORTC QLQ-STO22 score | up to 2 years | — |
| EQ-5D-5L score | up to 2 years | — |
| 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 | — |
| DCR in part 1 study | up to 2 years | Disease control rate (DCR) as assessed by the investigator per RECIST 1.1 |
| PFS in part 1 study | up to 2 years | Progression free survival (PFS) as assessed by the investigator per RECIST 1.1 |
Countries
China
Outcome results
None listed