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Gastric AdenocarcinomaPhase 3NCT05008783

A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma

A Phase 3 study testing AK104 in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Akeso at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomized, Double-blind, Multicenter, phase III Clinical Study of Comparing the Efficacy and Safety of AK104 Plus Oxaliplatin and Capecitabine (XELOX) Versus Placebo Plus XELOX as First-line Treatment for locally advanced Unresectable or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
AK104
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
610 participants
Where
7 sitesChina
Study dates
17 Sep 2021to 1 Aug 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Subjects must meet all of the following inclusion criteria to be enrolled in the study:
  • Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
  • Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
  • Histopathologically confirmed gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma.
  • Unresectable locally advanced or metastatic gastric adenocarcinoma or GEJ adenocarcinoma.
  • Subjects have not received prior systemic therapy for locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. For subjects who have received prior neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months.
  • Subjects have at least one measurable tumor lesion per RECIST v1.1; lesions that received radiotherapy are not selected as target lesions, unless the lesion is the only measurable lesion and has unequivocal progression as judged by imaging, it can be considered as a target lesion.

Who cannot join

  • Subjects who meet any of the following criteria are not eligible to participate in this study:
  • Subjects with known HER2-positive gastric or GEJ adenocarcinoma.
  • Histopathology or cytology confirmed other pathological types, such as squamous cell carcinoma, sarcoma, or undifferentiated carcinoma.
  • Subjects who received palliative local therapy for non-target lesions within 2 weeks prior to the first dose; systemic nonspecific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, etc.) within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 2 weeks prior to the first dose.
  • Subjects who received any prior treatments targeting the mechanism of tumor immunity.
  • Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose. If the perforation or fistula has been treated with resection or repair and the disease has recovered or resolved as judged by the Investigator, enrollment may be allowed.
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  • Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
  • Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of cervix, carcinoma in situ of breast, localized prostate cancer, etc.
  • Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease.
  • Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).
  • Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100143

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610044

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350014

  • The First Affiliated Hospital of Zhejiang University Medical College

    Hangzhou, Zhejiang, 310003

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 20032

Other trials in China

About this study

Official title: A Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of AK104 Plus Oxaliplatin and Capecitabine (XELOX) Versus Placebo Plus XELOX as First-line Treatment for Locally Advanced Unresectable or G/GEJ Adenocarcinoma

A randomized, Double-blind, Multicenter, phase III Clinical Study of Comparing the Efficacy and Safety of AK104 Plus Oxaliplatin and Capecitabine (XELOX) Versus Placebo Plus XELOX as First-line Treatment for locally advanced Unresectable or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma.

Being tested
AK104, Placebo

What participants receive

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

  • AK104Drug

    Also called Oxaliplatin, Capecitabine

    AK104 (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, Q3W,up to 6 cycles) . Afterward, AK104 will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W)

  • PlaceboDrug

    Also called Oxaliplatin, Capecitabine

    Placebo (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, Q3W,up to 6 cycles) . Afterward,Placebo will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W)

Study groups in NCT05008783
Study groupRoleWhat they receive
AK104 + Oxaliplatin + CapecitabineExperimentalAK104 in combination with Oxaliplatin and Capecitabine
Receives: Drug: AK104
Placebo + Oxaliplatin + CapecitabinePlacebo comparatorPlacebo in combination with Oxaliplatin and Capecitabine
Receives: Drug: Placebo

What is being measured

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

  1. Overall Survival (os)

    OS in the ITT population.

    Measured: Up to 2 years

Secondary outcomes (8)

  1. ORR

    ORR is the proportion of subjects with CR or PR based on RECIST v1.1

    Measured: Up to 2 years

  2. DCR

    DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1

    Measured: Up to 2 years

  3. DoR

    DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  4. TTR

    TTR is defined as the time to response base on RECIST v1.1

    Measured: Up to 2 years

  5. PFS

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1

    Measured: Up to 2 years

  6. AE

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.

    Measured: From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first

  7. Observed concentrations of AK104

    The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration

    Measured: From first dose of AK104 through the last dose of AK104, about average of 9 months.

  8. Number of subjects who develop detectable anti-drug antibodies (ADAs)

    The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).

    Measured: From first dose of AK104 through 30 days after last dose of AK104

Timeline

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

  1. First posted17 Aug 2021
  2. Study start17 Sep 2021
  3. Primary completion6 Dec 2024
  4. Study completion1 Aug 2025

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
610 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05008783
Sponsor's protocol ID
AK104-302
Status last verified
Nov 2025
First submitted
30 Jul 2021
Last updated
19 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shen L, Zhang Y, Li Z, Zhang X, Gao X, Liu B, Wang Y, Ba Y, Li N, Zhang R, Zhang J, Chen Y, Chen J, Huang M, Fu Y, Liu M, Liu Z, Zhao J, Li W, Wei J, Li C, Xu N, Guo Z, Cao B, Liu L, Nie P, Wan L, Sheng L, Liu Z, He Y, Gu K, Wu G, Wang W, Zhang F, Qiu W, Guo J, Ying J, Pan H, Xu H, Yuan Y, Bai Y, Wang Z, Xu J, Zhao X, Liu H, Zhang X, Dai W, Xu H, Liu M, Xie L, Tang Y, Jin J, Qu X, Fang X, Huang M, Chen H, Zheng Z, Wang Y, Wang D, Li X, Yu G, Liu H, Zhou Y, Zhong D, Zeng S, Kang M, Wang M, Gao Y, Li W, Wang Z, Zhang M, Zhang J, Li Q, Sun S, Zang A, Lin L, Xie M, Zhuang Z, Zhang T, Yao Z, Lu D, Liu W, Hu M, Wang ZM, Li B, Xia M, Zhang J, Ying X, Pardoll DM, Ji J. First-line cadonilimab plus chemotherapy in HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma: a randomized, double-blind, phase 3 trial. Nat Med. 2025 Apr;31(4):1163-1170. doi: 10.1038/s41591-024-03450-4. Epub 2025 Jan 22.

    PubMed 39843940

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AK104 in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Akeso at 7 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Survival (os) (time frame: Up to 2 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 NCT05008783, which also lists 1 linked publication.

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 19 Nov 2025.

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