SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection: SHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified days. Oxaliplatin: Specified dose on specified days. Capecitabine Tablets: Specified dose on specified days. Paclitaxel Injection: Specified dose on specified days. Cisplatin Injection: Specified dose on specified days.
Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection: Adebrelimab: Specified dose on specified days. Oxaliplatin Injection: Specified dose on specified days. Capecitabine Tablets: Specified dose on specified days. Paclitaxel Injection: Specified dose on specified days. Cisplatin Injection: Specified dose on specified days.
Study summary
Objective response rate (ORR) was evaluated to evaluate the efficacy of SHR-8068 combined with adebrelimab and platinum-containing chemotherapy in first-line treatment of advanced gastric and esophageal cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
2. Aged 18-75 at the time of signing the informed consent;
3. Histologically or cytologically confirmed, unresectable, advanced or recurrent/metastatic adenocarcinoma of the gastric or gastroesophageal junction, or unresectable or recurrent/metastatic esophageal squamous cell carcinoma without radical chemoradiation;
4. At least one measurable lesion consistent with RECIST v1.1;
5. ECOG PS score: 0-1;
6. The organ function level is good;
Exclusion Criteria:
1. Her2-positive patients;
2. Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
3. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
4. Previous or co-existing malignant neoplasms;
5. The presence of any active or known autoimmune disease;
6. People who have previously received an organ transplant;
7. Have clinical symptoms or diseases of the heart that are not well controlled;
8. Known allergic reactions to adebrelimab or other monoclonal antibodies or investigational drugs;
Primary outcome measure(s)
ORR based on RECIST v1.1 assessment. — All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years
Trial sites (1)
Facility
City
Region
Status
Chinese PLA General Hospital
Beijing
Beijing Municipality
More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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