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Immunotherapy combo aims to stop stomach cancer return after surgery

NCT ID NCT05180734

Disease control Sponsor: Shanghai Junshi Bioscience Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding the immunotherapy drug toripalimab to standard chemotherapy after stomach cancer surgery can help prevent the cancer from coming back. About 878 patients who had their stomach cancer completely removed will receive either toripalimab plus chemotherapy or a placebo plus chemotherapy. The study focuses on patients with PD-L1 positive tumors and measures how long they remain cancer-free.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
toripalimab (an immunotherapy drug) combined with chemotherapy
What this could lead to
If successful, this combination could become a new standard treatment after stomach cancer surgery, helping to delay or prevent the cancer from coming back.
What could go wrong
This is an early-phase trial, and the results may not show a clear benefit. Immunotherapy can cause side effects like inflammation in healthy organs, and not all patients respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

878 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA 1. Age 18-75 years. 2. No residual tumor (R0) after D2 or greater lymphadenectomy through laparotomy. 3. According to the definition of the 8th edition of the AJCC Cancer Staging Manual, patients with gastric adenocarcinoma confirmed by histopathology, pathological stage II (T4aN0M0) and stage III, including gastroesophageal junction adenocarcinoma (GEJ) patients. 4. Patients need to provide sufficient formalin-fixed paraffin-embedded (FFPE) neoplasm tissue specimens or sections that are confirmed to be PD-L1 positive (CPS ≥ 1) by lab test at the central laboratory. 5. ECOG performance status 0-1. 6. No metastasis or recurrence as radiologically confirmed. 7. Patients must have adequate organ function as assessed in the laboratory tests. 8. Patients must provide informed consent for this study, and sign the written informed consent form voluntarily before the initiation of the study, and are willing and able to comply with the scheduled visits, treatment plan, laboratory examinations and other study procedures in the study. 9. Female patients of childbearing age must take a serum pregnancy test within 7 days before randomization with negative results, and agree to adopt reliable and effective contraceptive methods during the study. EXCLUSION CRITERIA 1. Previous use of non-surgical therapy (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric adenocarcinoma. 2. Having liver, peritoneal or other distant metastasis. 3. Having malignant tumors other than gastric adenocarcinoma within 5 years before randomization. 4. Pevious treatment targeting PD-1 receptor or its ligand PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) receptor; 5. Previous history of serious allergy to monoclonal antibody or other biological preparations.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastroesophageal adenocarcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric or esophagogastric junction adenocarcinoma

Contacts and locations

Locations

  • Affiliated Cancer Hospital and Institute of Ghuangzhou Medical University

    Guangzhou, Guangdong, 510095, China

  • Affiliated Hospital of Jining Medical University

    Jining, Shangdong, 272007, China

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563099, China

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 510515, China

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050, China

  • Beijing Hospital

    Beijing, Beijing Municipality, 100005, China

  • Cancer Hospital affiliated to Xinjiang Medical University

    Ürümqi, Xinjiang, 830000, China

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033, China

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100000, China

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350011, China

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730050, China

  • Gansu Provincial People's Hospital

    Lanzhou, Gansu, 730000, China

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750000, China

  • Guandong General Hospital

    Guangzhou, Guandong, 510000, China

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530021, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Henan cancer hospital

    Zhengzhou, Henan, 450003, China

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hopital

    Changsha, Hunan, 410031, China

  • Jiangmen Central Hospital

    Nanchang, Jiangxi, 330006, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Jiangsu cancer hospital

    Nanjing, Jiangsu, 210000, China

  • Jinan Central Hospital

    Jinan, Shangdong, 250012, China

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730000, China

  • LiaoNing Cancer Hospital & Institute

    Shenyang, Liaoning, 110000, China

  • Linyi Cancer Hospital

    Linyi, Shandong, 276002, China

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226006, China

  • Peking University People's hospital

    Beijing, Beijing Municipality, 100044, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518000, China

  • Qingdao central medical group

    Qingdao, Shandong, 266042, China

  • Qinghai University Affiliated Hosptial

    Xining, Qinghai, 810000, China

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Shandong Provincial Hospital

    Jinan, Shangdong, 250031, China

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080, China

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030012, China

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518000, China

  • SiChuan Cancer Hospital

    Chengdu, Sichuan, 610000, China

  • Suining Central Hospital

    Suining, Sichuan, 629000, China

  • Tangdu hospital, Air force Military Medical University

    Xian, Shanxi, 710000, China

  • The 2ed Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003, China

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233300, China

  • The First Affiliated Hospital of Henan University of science and Technology

    Luoyang, Henan, 450052, China

  • The First Affiliated Hospital of Sun yat-sen University

    Guangzhou, Guangdong, 510080, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Hospital of China Medical University

    Shengyang, Liaoning, 110000, China

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, 314001, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213004, China

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528000, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011, China

  • The Peple's Hospital of Chizhou

    Chizhou, Anhui, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325024, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

  • The Second People's Hospital of Wuxi

    Wuxi, Jiangsu, 214001, China

  • The first Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The first Hospital of Lanzhou University

    Lanzhou, Gansu, 750050, China

  • The first affiliated hospital of Zhejiang medical university

    Hangzhou, Zhejiang, China

  • The first affiliated hospital of chongqing medical universit

    Chongqing, Chongqing Municipality, 400016, China

  • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • Wuwei Cancer Hospital of Gansu Province

    Wuwei, Gansu, 733000, China

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008, China

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021, China

  • Xijing hospital, Air force Military Medical University

    Xian, Shanxi, 710000, China

  • Yichang Central People's Hospital

    Yichang, Hubei, 443008, China

  • Yuebei People's Hospital

    Shaoguan, Guangdong, 512099, China

  • Zhongshan Hospital, Fudan university

    Shanghai, Shanghai Municipality, 200032, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guandong, 510280, China

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