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Efficacy and Safety of AK112 Combined Chemotherapy as Neoadjuvant Treatment for Signet Ring Cell-containing G/GEJ Adenocarcinoma

NCT07091227 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-07-29

No results posted yet for this study

Summary

Study Overview

The primary objective of this clinical trial is to evaluate the efficacy and safety of AK112 in combination with chemotherapy as a neoadjuvant treatment for patients with locally advanced, resectable gastric or gastroesophageal junction (G/GEJ) adenocarcinoma containing signet ring cells.

Key Research Questions

1. Does neoadjuvant treatment with AK112 plus chemotherapy improve the pathological complete response (pCR) rate compared to chemotherapy alone in patients with locally advanced G/GEJ adenocarcinoma with signet ring cells?
2. What are the safety profile and additional efficacy outcomes of AK112 combined with chemotherapy in this patient population?

To answer these questions, the study will compare the combination of AK112 and chemotherapy with chemotherapy alone.

Participant Procedures

Eligible participants will:

1. Receive standard-dose AK112 in combination with chemotherapy every 3 weeks for a total of 4 cycles prior to surgery.
2. Undergo preoperative CT or MRI imaging within 3-4 weeks after the last treatment cycle to assess tumor response and evaluate eligibility for curative resection.
3. If no evidence of disease progression is observed and surgical evaluation is favorable, patients will undergo curative-intent gastrectomy within 6 weeks of completing neoadjuvant therapy (including oral agents, if any).
4. Postoperatively, adjuvant therapy will be administered at the investigator's discretion. Patients will be followed until disease recurrence or metastasis.
5. Attend clinic visits every 6 weeks during the neoadjuvant phase for evaluations and laboratory tests.
6. Maintain a symptom diary throughout the study period.
7. Undergo follow-up assessments every 3 months, starting from the first dose of study medication until 30 days after the last dose or the initiation of a new anti-tumor therapy.

Optional Imaging Substudy FAPI-PET/CT imaging will be explored as an optional diagnostic modality. Participation in this substudy will require separate informed consent and will be conducted under a future protocol amendment (pending IRB approval).

Conditions

  • Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

AK112+oxaliplatin+capecitabine

participants will receive standard dose treatment of AK112 combined with oxaliplatin+capecitabine every 3 weeks for 4 cycles before surgery.

DRUG

oxaliplatin+capecitabine

participants will receive standard dose treatment of oxaliplatin+capecitabine every 3 weeks for 4 cycles before surgery

Sponsors & Collaborators

  • Akeso Biopharma Co., Ltd.

    collaborator UNKNOWN

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Yi Ba · Department of Cancer Medical Center, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing，100730

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-20
Primary Completion
2026-07-20
Completion
2029-07-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07091227 on ClinicalTrials.gov