Gastric and Gastroesophageal Junction (GEJ) AdenocarcinomaPhase 3NCT07023315
A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma
A Phase 3 study testing Cadonilimab and SOX chemotherapy in people with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, run by Akeso at 6 sites in China.
Trial summary
This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
- What is being tested?
- Cadonilimab and SOX chemotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 760 participants
- Where
- 6 sitesChina
- Study dates
- 14 Aug 2025to Jul 2031
- 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
- Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma with resectable disease (clinical stage T3-4aN+M0 or T4bNanyM0 per AJCC 8th edition).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
- Has life expectancy of at least 6 months.
- Availability of tumor sample prior to study entry.
- Patients must undergo radical surgery.
- Has adequate organ function.
Who cannot join
- Patients with unresectable locally advanced disease or distant metastasis.
- Histopathology or cytology confirmed other pathological types, such as adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
- Current or prior use of immunosuppressive medication within 14 days before randomization.
- Has received prior anti-cancer therapy for the current malignancy.
- Has an active infection requiring systemic therapy.
- Contra-indication to any of the study drugs.
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- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Known active Hepatitis B or Hepatitis C virus infection.
- Has had an allogenic tissue/solid organ transplant.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jiafu Ji, MD contact
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100143
Jiafu Ji, MD
Lin Shen, MD
- Recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian
Luchuan Chen, MD
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Yanqiao Zhang, MD
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
Yihong Sun, MD
- Recruiting
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Qun Zhao, MD
- Recruiting
Tianjin Provincial Tumor Hospital
Tianjin, Tianjin Municipality
Han Liang, MD
About this study
Official title: A Randomized, Double-blind, Phase III Clinical Study Comparing the Efficacy and Safety of Cadonilimab Plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) Versus Placebo Plus SOX as Perioperative Treatment for Patients With Resectable Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma
This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer.
Read the detailed description
This trial is a Phase 3 study. All patients are resectable gastric or gastroesophageal junction adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy for perioperative treatment of resectable gastric or gastroesophageal junction adenocarcinoma.
- Being tested
- Cadonilimab, SOX chemotherapy, Placebo
- Medical subject headings
- Adenocarcinoma
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
SOX chemotherapyDrug
A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| cadonilimab+SOX | Experimental | Cadonilimab plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) Receives: Drug: Cadonilimab; Drug: SOX chemotherapy |
| Placebo+SOX | Placebo comparator | Placebo plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) Receives: Drug: SOX chemotherapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
EFS is the time from date of randomization until the date of disease progression or death.
Measured: Up to 5 years
Pathological Complete Response (pathCR) Rate
PathCR rate is defined as the percentage of participants having a pathCR assessed by the investigators.
PathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.
Measured: Up to approximately 2 years
Secondary outcomes (3)
Overall survival (OS)
Overall survival is length of time from randomization until the date of death due to any cause.
Measured: Up to 10 years
Disease-free Survival (DFS)
DFS is defined as the time from post-surgery baseline scan until the first occurrence of local or distant recurrence or death from any cause.
Measured: Up to 5 years
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2025
- Study start14 Aug 2025
- Primary completionJul 2029 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric and Gastroesophageal Junction (GEJ) AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023315
- Sponsor's protocol ID
- AK104-310
- Status last verified
- Feb 2026
- First submitted
- 10 Jun 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Phase III Clinical Study Comparing the Efficacy and Safety of Cadonilimab Plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) Versus Placebo Plus SOX as Perioperative Treatment for Patients With Resectable Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07023315
- Acronym / sponsor ID
- AK104-310
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 16 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer.
Detailed description
This trial is a Phase 3 study. All patients are resectable gastric or gastroesophageal junction adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy for perioperative treatment of resectable gastric or gastroesophageal junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cadonilimab+SOX | Experimental | Drug: Cadonilimab, Drug: SOX chemotherapyCadonilimab plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) |
| Placebo+SOX | Placebo comparator | Drug: SOX chemotherapy, Drug: PlaceboPlacebo plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma with resectable disease (clinical stage T3-4aN+M0 or T4bNanyM0 per AJCC 8th edition).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
- Has life expectancy of at least 6 months.
- Availability of tumor sample prior to study entry.
- Patients must undergo radical surgery.
Key exclusion criteria (10 listed)
- Patients with unresectable locally advanced disease or distant metastasis.
- Histopathology or cytology confirmed other pathological types, such as adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
- Current or prior use of immunosuppressive medication within 14 days before randomization.
- Has received prior anti-cancer therapy for the current malignancy.
- Has an active infection requiring systemic therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CadonilimabAnti-PD-1/ CTLA-4 tetrameric bispecific antibody | Drug | cadonilimab+SOX |
| SOX chemotherapyA combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium | Drug | Placebo+SOX, cadonilimab+SOX |
| PlaceboPlacebo | Drug | Placebo+SOX |
Primary outcome
Event-free survival (EFS)
Time frame: Up to 5 years
EFS is the time from date of randomization until the date of disease progression or death.
Pathological Complete Response (pathCR) Rate
Time frame: Up to approximately 2 years
PathCR rate is defined as the percentage of participants having a pathCR assessed by the investigators. PathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.
3 secondary outcomes
Overall survival (OS)
Time frame: Up to 10 years
Disease-free Survival (DFS)
Time frame: Up to 5 years
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiafu Ji, MD contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cadonilimab and SOX chemotherapy in people with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, run by Akeso at 6 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Contact Zhifang Yao, MD (86-0760-89873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2026.