NCT05960955RecruitingPhase 2
Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
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
Source: ClinicalTrials.gov · Last updated 18 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin treatment of resectable Gastric or Gastroesophageal Junction Adenocarcinoma.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 17 Jul 2023
- Start date
- 13 Nov 2023
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Akeso
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05960955
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 13 Nov 2023 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.
- Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
Other illness
- Are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage.
- 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).
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Provincial Tumor Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.