Combining cadonilimab with chemotherapy for gastric cancer treatment
Phase II Clinical Study of Cadonilimab Combination With Chemotherapy With or Without the Anti-CD47 Antibody AK117 Neoadjuvant/Adjuvant Therapy for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
This study is testing if adding cadonilimab to chemotherapy can help people with stomach cancer before their surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Akeso Industry-sponsored |
| Drugs / interventions | cadonilimab, chemotherapy |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT05960955 on ClinicalTrials.gov |
What this trial studies
This Phase II trial evaluates the efficacy and safety of cadonilimab combined with chemotherapy, with or without AK117, in patients with resectable gastric or gastroesophageal junction adenocarcinoma. Participants must have a confirmed diagnosis and meet specific health criteria, including an ECOG performance status of 0 or 1. The study aims to determine the effectiveness of this combination treatment as a neoadjuvant therapy before surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of resectable gastric or gastroesophageal junction adenocarcinoma and an ECOG performance status of 0 or 1.
Not a fit: Patients with unresectable disease or those with active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with resectable gastric or gastroesophageal junction adenocarcinoma.
How similar studies have performed: While this approach is being explored in this trial, similar combination therapies have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be able and willing to provide written informed consent. * 18 to 75 years old. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Has a histologically confirmed diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma(G/GEJ). * Has Stage T3-4N+M0 G/GEJ (American Joint Committee on Cancer \[AJCC\]) * Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Has adequate organ function. Exclusion Criteria: * Are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage. * Is currently participating in a study of an investigational agent or using an investigational device. * Has undergone major surgery within 30 days of Study Day 1. * Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). * History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. * Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
Where this trial is running
Tianjin
- Tianjin Provincial Tumor Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Weifeng Song, MD
- Email: clinicaltrials@akesobio.com
- Phone: +86(0760)89873999
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.