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Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Phase 2RecruitingNCT05960955
Akeso90 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

90

Conditions

Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

CadonilimabDRUG

IV infusion,Specified dose on specified days

AK117DRUG

IV infusion,Specified dose on specified days

OxaliplatinDRUG

IV infusion,Specified dose on specified days

Tegafur-gimeracil-oteracil potassiumDRUG

Oral,Specified dose on specified days

DocetaxelDRUG

IV infusion,Specified dose on specified days

5-FluorouracilDRUG

IV infusion,Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years
Medical Language ↔ Plain English
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.

Locations (1)

Tianjin Provincial Tumor Hospital

Tianjin, China

RECRUITING

Outcomes

Primary Outcomes

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

pCR is defined the 0% residual viable tumor cells in the primary tumor and sampled lymph nodes

Time frame: Up to approximately 2 years

Secondary Outcomes

Major pathological response(MPR) rates

MPR is defined the ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes

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

Proportion of subjects whose tumor TNM stage decreased from baseline before surgery

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

Serum drug concentrations of cadonilimab and/or AK117 in individual subjects at different time points

Time frame: Up to approximately 2 years

ADA

Number of subjects with detectable anti-drug antibodies (ADA).

Time frame: Up to approximately 2 years

Central Contacts

Weifeng Song, MD

CONTACT

+86(0760)89873999clinicaltrials@akesobio.com

Han Liang, MD

CONTACT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.