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AzTrials

Gastric or Esophagogastric Junction AdenocarcinomaPhase 3NCT05180734

PD1 Combined With Chemotherapy for Adjuvant Treatment of Gastric Cancer

A Phase 3 study of Gastric or Esophagogastric Junction Adenocarcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 71 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This multicenter, randomized, double-blind phase III study intends to recruit about 878 patients, including PD-L1 positive 660 patients, who have received radical gastrectomy (R0 resection, D2 or more extended lymphadenectomy) with postoperative pathological stage IIB or III (AJCC Cancer Staging Manual, 8th Edition)… Read more about this study

Who is it for?
Ages 18 to 75 years
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
878 participants
Where
71 sitesChina
Study dates
10 Feb 2022to 31 Jul 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years.
  • No residual tumor (R0) after D2 or greater lymphadenectomy through laparotomy.
  • 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.
  • 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.
  • ECOG performance status 0-1.
  • No metastasis or recurrence as radiologically confirmed.
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  • Patients must have adequate organ function as assessed in the laboratory tests.
  • 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.
  • 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.

Who cannot join

  • Previous use of non-surgical therapy (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric adenocarcinoma.
  • Having liver, peritoneal or other distant metastasis.
  • Having malignant tumors other than gastric adenocarcinoma within 5 years before randomization.
  • Pevious treatment targeting PD-1 receptor or its ligand PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) receptor;
  • Previous history of serious allergy to monoclonal antibody or other biological preparations.

Trial locations and contacts

71 sites in 1 country.

71 sites in 1 country

China71 sites

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100000

  • Beijing Hospital

    Beijing, Beijing Municipality, 100005

  • Peking University People's hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 510515

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233300

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • Hunan Cancer Hopital

    Changsha, Hunan, 410031

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213004

  • SiChuan Cancer Hospital

    Chengdu, Sichuan, 610000

  • The Peple's Hospital of Chizhou

    Chizhou, Anhui

  • The first affiliated hospital of chongqing medical universit

    Chongqing, Chongqing Municipality, 400016

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528000

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350011

  • Guandong General Hospital

    Guangzhou, Guandong, 510000

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guandong, 510280

  • The First Affiliated Hospital of Sun yat-sen University

    Guangzhou, Guangdong, 510080

  • Affiliated Cancer Hospital and Institute of Ghuangzhou Medical University

    Guangzhou, Guangdong, 510095

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • The first affiliated hospital of Zhejiang medical university

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • The 2ed Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, 314001

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Jinan Central Hospital

    Jinan, Shangdong, 250012

  • Shandong Provincial Hospital

    Jinan, Shangdong, 250031

  • Affiliated Hospital of Jining Medical University

    Jining, Shangdong, 272007

  • Gansu Provincial People's Hospital

    Lanzhou, Gansu, 730000

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730000

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730050

  • The first Hospital of Lanzhou University

    Lanzhou, Gansu, 750050

  • Linyi Cancer Hospital

    Linyi, Shandong, 276002

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

    Luoyang, Henan, 450052

  • Jiangmen Central Hospital

    Nanchang, Jiangxi, 330006

  • The first Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Jiangsu cancer hospital

    Nanjing, Jiangsu, 210000

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530021

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226006

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

  • Qingdao central medical group

    Qingdao, Shandong, 266042

  • Zhongshan Hospital, Fudan university

    Shanghai, Shanghai Municipality, 200032

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Yuebei People's Hospital

    Shaoguan, Guangdong, 512099

  • The First Hospital of China Medical University

    Shengyang, Liaoning, 110000

  • LiaoNing Cancer Hospital & Institute

    Shenyang, Liaoning, 110000

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518000

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518000

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • Suining Central Hospital

    Suining, Sichuan, 629000

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030012

  • Cancer Hospital affiliated to Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325024

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

    Wuhan, Hubei, 430022

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • Wuwei Cancer Hospital of Gansu Province

    Wuwei, Gansu, 733000

  • The Second People's Hospital of Wuxi

    Wuxi, Jiangsu, 214001

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Tangdu hospital, Air force Military Medical University

    Xian, Shanxi, 710000

  • Xijing hospital, Air force Military Medical University

    Xian, Shanxi, 710000

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021

  • Qinghai University Affiliated Hosptial

    Xining, Qinghai, 810000

  • Yichang Central People's Hospital

    Yichang, Hubei, 443008

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750000

  • Henan cancer hospital

    Zhengzhou, Henan, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563099

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection Combined With Postoperative Adjuvant Chemotherapy Versus Placebo Combined With Postoperative Adjuvant Chemotherapy in Patients With Gastric or Esophagogastric Junction Adenocarcinoma After Radical Gastrectomy

This multicenter, randomized, double-blind phase III study intends to recruit about 878 patients, including PD-L1 positive 660 patients, who have received radical gastrectomy (R0 resection, D2 or more extended lymphadenectomy) with postoperative pathological stage IIB or III (AJCC Cancer Staging Manual, 8th Edition) gastric or EGJ adenocarcinoma to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy.

Read the detailed description

"This is a multicenter, randomized, double-blind phase III study, plans to recruit 878 patients who received radical gastrectomy (R0, D2 or higher lymphadenectomy) with postoperative pathological stage II (T4aN0M0) or III (the 8th Edition American Joint Committee on Cancer [AJCC] Cancer Staging Manual) gastric adenocarcinoma and gastroesophageal junction adenocarcinoma, and the study intends to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy.

Patients meeting the inclusion criteria will be 1:1 randomized into JS001-chemotherapy group and placebo-chemotherapy group. The random stratification factors include adjuvant chemotherapeutic regimens (XELOX versus SOX) and tumor anatomical sites (gastric adenocarcinoma versus gastroesophageal junction adenocarcinoma).

The study treatment will be initiated 4-6 weeks after surgery, and the investigator will select XELOX (Oxaliplatin + capecitabine) or SOX (Oxaliplatin + S-1, tegafur, gimeracil and oteracil potassium) as the adjuvant chemotherapeutic regimen given as 3-week cycles for up to 8 cycles based on each patient's condition; JS001/placebo will be given for up to 17 cycles after surgery, until intolerable toxicity, disease recurrence, patient's withdrawal of consent, investigator's judgment that the patient needs to be withdrawn from the study treatment, or death, whichever comes first.

Safety evaluation, including vital signs, ECOG score, physical examination and laboratory examinations, will be performed on a regular basis during the treatment.

This study will end after the main analysis node of DFS and unblinding for analysis are achieved, or 5 years after enrollment of the last patient, whichever comes first. The Sponsor is entitled to terminate the study at any time due to specific reasons (e. g, major safety issues, force majeure, etc.).

Radiological follow-up: tumor response evaluation will be performed once every 12 weeks ±7 days within the first 5 years after randomization, and once per year subsequently, until disease recurrence or death. When symptoms or signs of suspected recurrence/metastasis occur, the radiological evaluation can be performed at any time. Disease recurrence is defined as local recurrence or distant metastases with clear radiological evidence (CT or MRI).

Survival follow-up: it will be performed once every 12 weeks after disease recurrence, until patient's withdrawal of informed consent, loss to follow-up or death, whichever comes first.

Safety follow-up: adverse events will be closely followed up and recorded, until 60 days after the last dose of treatment or the end of study follow-up (death, loss to follow-up, withdrawal of consent form and the end of study), whichever comes first.

"

Being tested
JS001/Placebo, JS001/placebo combine with Postoperative Adjuvant Chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JS001/PlaceboBiological

    Also called Postoperative Adjuvant Chemotherapy

    JS001/placebo combine with Postoperative Adjuvant Chemotherapy

  • JS001/placebo combine with Postoperative Adjuvant ChemotherapyBiological

    Also called Postoperative Adjuvant Chemotherapy

    JS001/placebo combine with Postoperative Adjuvant Chemotherapy

Study groups in NCT05180734
Study groupRoleWhat they receive
JS001 240mg, Q3W with XELOX regimen or SOX regimenExperimentalJS001 240mg, will be intravenously administered once every 3 weeks, until 17 cycles XELOX regimen (oxaliplatin + capecitabine) or SOX regimen (oxaliplatin + S-1), given in one therapeutic cycle of 3 weeks for up to 8 cycles XELOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; capecitabine, 1000mg/m2, orally, twice per day, from day 1 to day 14, Q3W. SOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; S-1 Capsules, 40-60mg, orally, twice per day, from day 1 to day 14, Q3W.
Receives: Biological: JS001/Placebo
Placebo combine with chemotherapyPlacebo comparatorXELOX regimen (oxaliplatin + capecitabine) or SOX regimen (oxaliplatin + S-1), given in one therapeutic cycle of 3 weeks for up to 8 cycles XELOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; capecitabine, 1000mg/m2, orally, twice per day, from day 1 to day 14, Q3W. SOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; S-1 Capsules, 40-60mg, orally, twice per day, from day 1 to day 14, Q3W.
Receives: Biological: JS001/placebo combine with Postoperative Adjuvant Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DFS in the PD-L1-positive population evaluated by the BICR

    To evaluate the disease-free survival (DFS) by the blind independent central review (BICR) for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in PD-L1-positive patients with gastric or GEJ adenocarcinoma after radical gastrectomy.

    Measured: 5 years

Secondary outcomes (10)

  1. OS in the PD-L1-positive population

    To evaluate the OS for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in PD-L1-positive patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.Toripalimab Injection (JS001) combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.

    Measured: 5 years

  2. DFS in the PD-L1-positive population evaluated by the investigator

    To evaluate the disease-free survival (DFS) by the investigator for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in PD-L1-positive patients with gastric or GEJ adenocarcinoma after radical gastrectomy.

    Measured: 5 years

  3. DFS in the ITT population evaluated by the BICR and investigator, respectively

    To evaluate the disease-free survival (DFS) by the blind independent central review (BICR) and investigator,respectively, for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the ITT population.

    Measured: 5 years

  4. OS in the ITT population

    To evaluate the OS for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the ITT population.

    Measured: 5 years

  5. DFS rate at 3 years in the PD-L1-positive population and the ITT population evaluated by the BICR and investigator, respectively

    To evaluate the disease-free survival (DFS) rate at 3 years by the BICR and investigator, respevtively, for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the PD-L1-positive population and the ITT population.

    Measured: 3 years

  6. DFS rate at 5 years in the PD-L1-positive population and the ITT population evaluated by the BICR and investigator, respectively

    To evaluate the disease-free survival (DFS) rate at 5 years by the BICR and investigator, respevtively, for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the PD-L1-positive population and the ITT population.

    Measured: 5 years

  7. OS rate at 3 years in the PD-L1-positive population and the ITT population

    To evaluate the OS rate at 3 years for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the PD-L1-positive population and the ITT population.

    Measured: 3 years

  8. OS rate at 5 years in the PD-L1-positive population and the ITT population

    To evaluate the OS rate at 5 years for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the PD-L1-positive population and the ITT population.

    Measured: 5 years

  9. Immunogenicity of toripalimab

    To evaluate the incidence and titer of anti-drug antibody (ADA) of toripalimab, and further analyze ADA-positive samples for the presence of Neutralising antibodies (Nab).

    Measured: Up to the 90 days from last dose of toripalimab

  10. Blood trough concentration of toripalimab

    To evaluate the blood trough concentration of toripalimab

    Measured: Up to the 90 days from last dose of toripalimab

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study start10 Feb 2022
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
878 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05180734
Sponsor's protocol ID
JS001-045-III-GC
Status last verified
Jul 2026
First submitted
8 Nov 2021
Last updated
7 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Gastric or Esophagogastric Junction Adenocarcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 71 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DFS in the PD-L1-positive population evaluated by the BICR (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05180734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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