---
title: Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
nct_id: NCT05960955
overall_status: RECRUITING
phase: PHASE2
sponsor: Akeso
study_type: INTERVENTIONAL
primary_condition: Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05960955.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05960955"
ct_last_update_post_date: 2023-11-18
last_seen_at: "2026-05-12T07:32:34.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

**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

**NCT ID:** [NCT05960955](https://clinicaltrials.gov/study/NCT05960955)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** Akeso
- **Conditions:** Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
- **Start Date:** 2023-11-13
- **Completion Date:** 2027-11-30
- **CT.gov Last Update:** 2023-11-18

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Part 1 cohort 1** (EXPERIMENTAL) — Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles.
- **Part 1 cohort 2** (EXPERIMENTAL) — Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles.
- **Part 2 cohort 1** (EXPERIMENTAL) — Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles.
- **Part 2 cohort 2** (EXPERIMENTAL) — Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles.

## Interventions

- **Cadonilimab** (DRUG) — IV infusion,Specified dose on specified days
- **AK117** (DRUG) — IV infusion,Specified dose on specified days
- **Oxaliplatin** (DRUG) — IV infusion,Specified dose on specified days
- **Tegafur-gimeracil-oteracil potassium** (DRUG) — Oral,Specified dose on specified days
- **Docetaxel** (DRUG) — IV infusion,Specified dose on specified days
- **5-Fluorouracil** (DRUG) — IV infusion,Specified dose on specified days

## 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** _(time frame: Up to approximately 2 years)_ — pCR is defined the 0% residual viable tumor cells in the primary tumor and sampled lymph nodes

## Secondary Outcomes

- **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)_

## Locations (1)

- Tianjin Provincial Tumor Hospital, Tianjin, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.tianjin provincial tumor hospital|tianjin||china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05960955.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05960955*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*