Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma

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

A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma (NCT07023315) is a Phase 3 interventional studying Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, sponsored by Akeso. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 760 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients with diagnosed by tissue sample (biopsy-confirmed) gastric or gastroesophageal junction adenocarcinoma with resectable disease (clinical stage T3-4aN+M0 or T4bNanyM0 per AJCC 8th edition). 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment. 3. Has expected to live at least 6 months. 4. Availability of tumor sample prior to study entry. 5. Patients must undergo radical surgery. 6. Has your organs (liver, kidneys, etc.) are working well enough based on blood tests. Who Should NOT Join This Trial: 1. Patients with unresectable locally advanced disease or distant metastasis. 2. Histopathology or cytology confirmed other pathological types, such as adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor. 3. Current or prior use of immunosuppressive medication within 14 days before randomization. 4. Has received prior anti-cancer therapy for the current malignancy. 5. Has an active infection requiring systemic therapy. 6. Contra-indication to any of the study drugs. 7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. 8. Has an active autoimmune conditions (where your immune system attacks your own body) that has required systemic treatment in past 2 years. 9. Known active Hepatitis B or Hepatitis C virus infection. 10. Has had an allogenic tissue/solid organ transplant. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma with resectable disease (clinical stage T3-4aN+M0 or T4bNanyM0 per AJCC 8th edition). 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment. 3. Has life expectancy of at least 6 months. 4. Availability of tumor sample prior to study entry. 5. Patients must undergo radical surgery. 6. Has adequate organ function. Exclusion Criteria: 1. Patients with unresectable locally advanced disease or distant metastasis. 2. Histopathology or cytology confirmed other pathological types, such as adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor. 3. Current or prior use of immunosuppressive medication within 14 days before randomization. 4. Has received prior anti-cancer therapy for the current malignancy. 5. Has an active infection requiring systemic therapy. 6. Contra-indication to any of the study drugs. 7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. 8. Has an active autoimmune disease that has required systemic treatment in past 2 years. 9. Known active Hepatitis B or Hepatitis C virus infection. 10. Has had an allogenic tissue/solid organ transplant.

Treatments Being Tested

DRUG

Cadonilimab

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

DRUG

SOX chemotherapy

A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium

DRUG

Placebo

Locations (6)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Tianjin Provincial Tumor Hospital

Tianjin, Tianjin Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07023315), the sponsor (Akeso), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07023315 clinical trial studying?

Who can participate in NCT07023315?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07023315?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07023315. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07023315. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.