Treatment for advanced gastric and esophageal cancer using a new drug combination
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
This study is testing a new combination of drugs to see if it can help people with advanced stomach and esophageal cancer feel better and respond to treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Drugs / interventions | adebrelimab, radiation, chemotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06247956 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of SHR-8068 combined with adebrelimab and platinum-containing chemotherapy in patients with advanced gastric adenocarcinoma and esophageal squamous cell carcinoma. The study aims to assess the objective response rate (ORR) as a measure of treatment effectiveness. Participants will receive a combination of SHR-8068, adebrelimab, and various chemotherapy agents including oxaliplatin and capecitabine. The trial is designed for patients who have unresectable or recurrent forms of these cancers and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with unresectable advanced gastric or esophageal cancer who have not received prior radical treatment.
Not a fit: Patients with Her2-positive tumors or untreated central nervous system metastasis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced gastric and esophageal cancers.
How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in treating advanced cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Beijing, Beijing
- Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Mengbo Zhao
- Email: mengbo.zhao@hengrui.com
- Phone: 0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.