Clinical trial · Interventional
Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the Treatment of Advanced Gastric and Esophageal Cancer
A Randomized, Open, Multicenter Phase II Clinical Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the First-line Treatment of Advanced Gastric and Esophageal Cancer
NCT06247956CI-TRIAL-00094429active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Adenocarcinoma and Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection | Drug | — | UNRESOLVED |
| SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-8068 combined with adebrelimab and platinum-containing chemotherapy
- interventionNames
- Drug: SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection
- type
- ACTIVE_COMPARATOR
- label
- Adebrelimab combined with platinum-containing chemotherapy
- interventionNames
- Drug: Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection
Primary outcomes (1)
- measure
- ORR based on RECIST v1.1 assessment.
- timeFrame
- All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.