Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cadonilimab, AK117, Oxaliplatin, Tegafur-gimeracil-oteracil potassium.
- Who it may be relevant to
- Registry conditions: Resectable Gastric or Gastroesophageal Junction Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug Cadonilimab
IV infusion,Specified dose on specified days - Drug AK117
IV infusion,Specified dose on specified days - Drug Oxaliplatin
IV infusion,Specified dose on specified days - Drug Tegafur-gimeracil-oteracil potassium
Oral,Specified dose on specified days - Drug Docetaxel
IV infusion,Specified dose on specified days - Drug 5-Fluorouracil
IV infusion,Specified dose on specified days
Primary outcome measures
- Incidence and severity of adverse events (AE), rate of surgical delays, abnormal laboratory findings of clinical significance [Time frame: Up to approximately 2 years]
- Pathological complete response (pCR) rates [Time frame: Up to approximately 2 years]
Secondary outcome measures (9)
- Major pathological response(MPR) rates [Time frame: Up to approximately 2 years]
- Tumor regression grade(TRG) [Time frame: Up to approximately 2 years]
- R0 resection rate [Time frame: Up to approximately 2 years]
- Tumor descending stage rate [Time frame: Up to approximately 2 years]
- ORR [Time frame: Up to approximately 2 years]
- EFS [Time frame: Up to approximately 2 years]
- OS [Time frame: Up to approximately 2 years]
- PK [Time frame: Up to approximately 2 years]
- ADA [Time frame: Up to approximately 2 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Provincial Tumor Hospital — Tianjin
Identifiers
NCT: NCT05960955 · AK104-219