UnknownPhase 2

To Evaluate the Efficacy and Safety of Cadonilimab With SOX as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

37 participantsStarted 2023-07

Plain-language summary

The Purpose of This Study is to Evaluate the Efficacy and Safety of Cadonilimab（AK104） in Combination With SOX as Neoadjuvant Therapy for Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18-75 years.
. Histologically or cytologically confirmed diagnosis of adenocarcinoma locate at gastroesophageal junction or stomach, advanced gastric or gastroesophageal junction cancer as assessed by ultrasonography and/or CT/MRI (cT3-T4a, N+, M0).
. Resectable gastric or gastroesophageal cancer, judged by surgeons in this study.
. No previous anti-tumor treatment.
. The expected survival is no less than 3 months.
. ECOG PS≤1.
. Adequate organ function including the following:
. Strict contraception.

Exclusion criteria

. Unable to comply with the research program or procedures.
. Undergoing other drug clinical trials, or has participated in any drug clinical trials one month before enrollment.
. Active autoimmune disease or history of refractory autoimmune disease.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pathological complete response rate (pCR)

Timeframe: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

Trial details

NCT IDNCT05948449

SponsorSichuan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01

Contact for this trial

Jiankun Hu, M.D

+86-18980601504 hujiankun@wchscu.cn

View on ClinicalTrials.gov More Gastric Cancer trials