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Gastric / Gastroesophageal Junction AdenocarcinomaPhase 3G/GEJNCT07700979

Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolumab for the 1L Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric/GEJ Adenocarcinoma

A Phase 3 study testing Cadonilimab, CAPOX regimen and Nivolumab in people with Gastric / Gastroesophageal Junction Adenocarcinoma, run by Akeso at 25 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

The goal of this randomized, double-blind, multi-regional phase 3 study of cadonilimab combined with chemotherapy versus chemotherapy in combination with or without nivolumab for the first-line treatment of participants with HER2-negative, previously untreated, unresectable or metastatic gastric or gastroesophageal… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cadonilimab, CAPOX regimen and Nivolumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
900 participants
Where
25 sitesin 4 countries
Study dates
24 Sep 2026to 18 Aug 2030
Phase
Phase 3

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide written informed consent and can understand and comply with the requirements of the study.
  • Histopathologically-confirmed diagnosis of locally advanced unresectable or metastatic G/GEJ adenocarcinoma.
  • No prior systemic therapy for locally advanced unresectable or metastatic G/GEJ adenocarcinoma. NOTE: For participants who have received prior neoadjuvant/adjuvant therapy for curative intent, the time between disease progression and last treatment should be at least 6 months.
  • ECOG PS of 0 or 1 within 3 days prior to randomization.
  • Age ≥ 18 years at the time of voluntarily signing informed consent.
  • Evaluable PD-L1 expression results.
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  • Participants must have at least one measurable lesion per RECIST v1.1 as assessed by investigator assessment. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Adequate organ function as indicated by the following laboratory values. Specimens must be collected within 7 days prior to the first dose of study treatment.
  • Life expectancy ≥3 months.
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during treatment, and for at least 150 days after the last dose of cadonilimab/nivolumab, 270 days after the last dose of oxaliplatin, and 180 days after the last dose of capecitabine.
  • Non-sterile males must agree to use effective contraception during treatment and for at least 120 days following the last dose of cadonilimab/nivolumab/capecitabine and 180 days after the last dose of oxaliplatin.

Who cannot join

  • Histopathologically confirmed other pathological types, such as squamous cell carcinoma, sarcoma or undifferentiated carcinoma.
  • Known HER2 positive. Be HER2-positive defined as either IHC 3+ or IHC 2+ in combination with ISH+ (or FISH).
  • Participants with active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
  • Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1 time/month).
  • Clinically significant bleeding symptoms within 28 days before the first dose or a definite tendency to bleed.
  • Have a history of ≥ Grade 2 gastrointestinal perforation and/or fistulae (including prior gastric fistula operation) within 6 months prior to randomization.
  • Participants who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.

Trial locations and contacts

25 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Zhifang Yao, MD contact

86-0760-89873999

clinicaltrials@akesobio.com

Yelena Janjigian, MD contact

25 sites in 4 countries

United States13 sites, 13 recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Not yet recruiting

  • Baylor Scott & White Health

    Dallas, Texas, 75246

    Not yet recruiting

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

    Allen L Cohn, MD

    Not yet recruiting

  • Henry Ford Health

    Detroit, Michigan, 48202

    Zaid AI-Saheli, MD

    Not yet recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Jaffer A. Ajani,, MD

    Not yet recruiting

  • UCLA Health

    Los Angeles, California, 90095

    Randy Hecht, MD

    Not yet recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

    Nataliya Uboha, MD

    Not yet recruiting

  • Sarah Cannon Research Institute (SCRI) - Oncology Partners

    Nashville, Tennessee, 37203

    David R Spigel, MD

    Not yet recruiting

  • Yale School of Medicine

    New Haven, Connecticut, 06510

    Raghav Sundar, MD

    Not yet recruiting

  • Mount Sinai

    New York, New York, 10029

    Deirdre Cohen, MD

    Not yet recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Yelena Janjigian, MD

    Not yet recruiting

  • Mayo Clinic

    Phoenix, Arizona, 85054

    Ashish Chintakuntlawar,

    Not yet recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Emerson Chen, MD

    Not yet recruiting

Other trials in United States

China5 sites, 5 recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

    Wei Deng, MD

    Not yet recruiting

  • Peking University Cancer Hospital, Gastrointestinal Cancer Center I

    Beijing

    Jiafu Ji, MD

    Recruiting

  • Peking University Cancer Hospital, Gastrointestinal Oncology

    Beijing

    Lin Shen, MD

    Not yet recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou

    Jian Xiao, MD

    Not yet recruiting

  • Zhongshan Hospital Fudan University

    Shanghai

    Xuefei Wang, MD

    Not yet recruiting

Other trials in China

Germany4 sites, 4 recruiting

  • Universitaetsklinikum Essen

    Essen, North Rhine-Westphalia

    Isabel Virchow, MD

    Not yet recruiting

  • University Cancer Center Frankfurt

    Frankfurt

    Thorsten O Goetze, MD

    Not yet recruiting

  • Universitätsmedizin der Johannes Gutenberg-Universität

    Mainz

    Markus Mohler, MD

    Not yet recruiting

  • Univerity Marburg

    Marburg

    Not yet recruiting

Other trials in Germany

Poland3 sites, 3 recruiting

  • Pratia MCM Kraków

    Krakow

    Not yet recruiting

  • Pratia Poznań

    Poznan

    Piotr Tomczak, MD

    Not yet recruiting

  • Narodowy Instytut Onkologii-im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy - w Warszawie

    Warsaw

    Lucjan S Wyrwicz, MD

    Not yet recruiting

Other trials in Poland

About this study

Official title: A Randomized, Double-blind, Multi-regional Phase 3 Study of Cadonilimab Combined With Chemotherapy Versus Chemotherapy in Combination With or Without Nivolumab for the First-line Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

The goal of this randomized, double-blind, multi-regional phase 3 study of cadonilimab combined with chemotherapy versus chemotherapy in combination with or without nivolumab for the first-line treatment of participants with HER2-negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma trial is to compare OS between cadonilimab combined with chemotherapy and chemotherapy in combination with or without nivolumab in the ITT population.

Being tested
Cadonilimab, CAPOX regimen, Nivolumab, Placebo
Keywords
Gastric/GEJ adenocarcinoma, gastric cancer, cadonilimab, nivolumab, chemotherapy, HER2-negative cancer, Immunotherapy
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • CadonilimabDrug

    Anti-PD-1/ CTLA-4 tetrameric bispecific antibody

  • CAPOX regimenDrug

    A combination treatment contains oxaliplatin and capecitabine

  • NivolumabDrug

    Anti-PD-1 monoclonal antibody

  • PlaceboDrug

    Placebo

Study groups in NCT07700979
Study groupRoleWhat they receive
Cadonilimab/placebo+CAPOXExperimentalCadonilimab/placebo in combination with oxaliplatin and capecitabine (CAPOX)
Receives: Drug: Cadonilimab; Drug: CAPOX regimen; Drug: Placebo
CAPOX±nivolumab/placeboActive comparatorOxaliplatin and capecitabine with or without nivolumab (CAPOX)
Receives: Drug: CAPOX regimen; Drug: Nivolumab; Drug: Placebo

What is being measured

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

  1. Overall survival (OS)

    Time from randomization to death from any cause

    Measured: Approximately up to 14months

Secondary outcomes (5)

  1. Progression-free survival(PFS)

    Time from the date of randomization to the date of progressive disease or death from any cause, whichever occurs first.

    Measured: Approximately up to 8 months

  2. Objective response rate (ORR)

    Measured: Approximately up to 8 months

  3. Disease control rate (DCR)

    Measured: Approximately up to 8 months

  4. Duration of response (DoR)

    Measured: Approximately up to 8 months

  5. Safety assessment

    Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results

    Measured: Approximately up to 18 months

Timeline

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

  1. First posted14 Jul 2026
  2. Study start24 Sep 2026
  3. Primary completion18 Aug 2029 (estimated)
  4. Study completion18 Aug 2030 (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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07700979
Sponsor's protocol ID
AK104-311
Acronym
G/GEJ
Status last verified
Jun 2026
First submitted
8 Jul 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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