Phase 3 Stomach Cancer Trial, Recruiting NCT04997837 Sponsor: Fudan University Condition: Stomach Cancer
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Phase 3 Stomach Cancer Trial, Recruiting

NCT04997837
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are generally able to carry out daily activities with little or no limitation (as measured by a standard health score of 0 or 1)
  • Your doctors expect you to live for more than 6 months
  • You have had a specific type of stomach surgery (called D2/R0 resection) that is considered the standard treatment
  • After surgery, your tumor was confirmed by lab testing to be a type of cancer called adenocarcinoma, located in the stomach or where the stomach meets the food pipe
  • More than 7 of your lymph nodes tested positive for cancer (stage pN3)
  • The cancer has not spread to distant parts of the body, or if there are cancer cells detected in the abdominal fluid, there are no visible spread of tumors in the abdomen (confirm with trial site)
  • Your overall health and organ function allow you to receive additional treatments after surgery, including chemotherapy, radiation with chemotherapy, and an immune therapy drug
  • Your blood test results meet specific minimum levels for red blood cells, white blood cells, platelets, liver function, and kidney function (confirm with trial site for exact values)
  • You are willing and able to follow the treatment plan during the study
  • You have given written agreement to take part and understand you can leave the study at any time without affecting your other care
  • You are willing to provide blood and tissue samples for the study

Who may not be able to join:

  • Your cancer has visibly spread throughout the lining of the abdomen or to distant parts of the body
  • You received any cancer treatment before your surgery
  • You have previously had radiation therapy to abdominal organs such as the stomach, liver, or kidneys
  • You have had an active autoimmune disease requiring treatment within the past 2 years (simple replacement therapies like thyroid hormone or insulin are generally not excluded — confirm with trial site)
  • You have been diagnosed with a weakened immune system, or have taken steroid or immune-suppressing medications within 7 days before starting the study (very low-dose steroids may be allowed — confirm with trial site)
  • You have had a known severe allergic reaction to any of the study drugs, including the immune therapy drug, chemotherapy drugs (5-FU or Oxaliplatin), or their ingredients
  • You have been diagnosed with another type of cancer in the past 5 years, unless it was a fully treated early skin cancer or a fully removed non-invasive cancer
  • You have serious failure of a major organ
  • You are pregnant or breastfeeding
  • You have a known mental health condition or substance abuse problem that could affect your ability to follow the study plan
  • You are known to have HIV infection or active tuberculosis
  • You have untreated, active hepatitis B
  • You have active hepatitis C infection
  • You have other health complications that are not well controlled
  • There are other circumstances that the trial team believes could affect the study results or your ability to participate (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Zhen Zhang, MD,PhD, Fudan University

Phone: 18801735029

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
21 July 2021
Est. completion
21 July 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

3-year DFS rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov