Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the Treatment of Advanced Gastric and Esophageal Cancer

Phase 2

Recruiting

• Conditions: Advanced Gastric Adenocarcinoma and Esophageal Squamous Cell Carcinoma
• Interventions: Drug: SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection; Drug: Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection

• Registration Number: NCT06247956
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-08
• Study Start: 2024-03-11
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
SHR-8068 combined with adebrelimab and platinum-containing chemotherapy	SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection	-
Adebrelimab combined with platinum-containing chemotherapy	Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
DCR 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 Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China