A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer
- Conditions
- Gastric or Gastroesophageal Junction Cancer
- Registration Number
- NCT04950322
- Lead Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 737
Inclusion Criteria:<br><br> 1. Pathologically confirmed diagnosis of locally advanced unresectable or metastatic<br> gastric or gastroesophageal junction (GEJ)adenocarcinoma.<br><br> 2. HER2 overexpression or amplification negative.<br><br> 3. Female or male, 18 years of age or above.<br><br> 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.<br><br> 5. Patients who are willing and able to provide the signed informed consent form,<br> willing and able to comply with all the scheduled visits, study treatment,<br> laboratory tests, and other study procedures.<br><br>Exclusion Criteria:<br><br> 1. Squamous cell carcinoma, undifferentiated carcinoma, or other histological types of<br> gastric cancer.<br><br> 2. Presence of inadequately treated CNS metastases, or uncontrolled or symptomatic<br> active CNS metastases ,leptomeningeal disease, and/or rapid progression.<br><br> 3. Presence of uncontrolled pleural effusion or ascites despite puncture drainage<br> within 14 days prior to randomization.<br><br> 4. More than 20% weight loss within 2 months prior to randomization.<br><br> 5. Diagnosed with other malignant tumors within 5 years prior to enrollment.<br><br> 6. Presence of any active, known or suspected autoimmune disease.<br><br> 7. Prior treatment with TGF-ß inhibitor, anti-PD-1/PD-L1 antibodies, anti-PD-L2<br> antibodies, anti-CD137 antibodies, anti-CTLA-4 antibodies, or other<br> drugs/antibodies.<br><br> 8. Severe, unhealed, or dehisced wounds and active ulcers or untreated fractures.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AEs and SAEs in part 1 study;Overall survival in subjects with PD-L1 CPS = 5 in part 2 study;OS in all subjects in part 2 study
- Secondary Outcome Measures
Name Time Method ORR in part 1 study;DCR in part 1 study;PFS in part 1 study;DoR in part 1 study;OS in part 1 study;PFS in part 2 study;ORR in part 2 study;DCR in part 2 study;DoR in part2 study;PFS in subjects with PD-L1 CPS =5 and in all subjects as assessed by investigator as per RECIST 1.1;ORR in part 2 study;DCR in part 2 study;DoR in part 2 study;AEs and SAEs in part 2 study;EORTC QLQ-C30 score;EORTC QLQ-STO22 score;EQ-5D-5L score