NCT07091227

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

Not yet recruiting Phase 2 Last updated 29 July 2025

What this trial tests

Phase 2 trial testing AK112+oxaliplatin+capecitabine in Gastric or Gastroesophageal Junction Adenocarcinoma in 66 participants. Not yet recruiting.

Timeline

20 July 2025

Primary endpoint
20 July 2026

20 July 2029

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	66
Start date	20 July 2025
Primary completion	20 July 2026
Estimated completion	20 July 2029
Sites	1 location across China

Drugs / interventions tested

• AK112+oxaliplatin+capecitabine — full drug profile →
• oxaliplatin+capecitabine

Conditions studied

• Gastric or Gastroesophageal Junction Adenocarcinoma — all drugs for Gastric or Gastroesophageal Junction Adenocarcinoma →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 75, any sex, with Gastric or Gastroesophageal Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.