Phase 2 Stomach Cancer Trial, Recruiting NCT05536102 Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Condition: Stomach Cancer
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Phase 2 Stomach Cancer Trial, Recruiting

NCT05536102
Recruiting Phase 2

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:

  • People aged between 18 and 75 years old.
  • People whose general health and ability to carry out daily activities meets a minimum threshold on a standard medical scoring scale (confirm with trial site).
  • People who have been confirmed through tissue or cell testing to have a specific type of stomach cancer called gastric adenocarcinoma, where the cancer tests negative for a protein called HER2, and positive for a marker called PD-1/L1.
  • People whose stomach cancer is classified as stage III according to a standard cancer staging system.
  • People whose overall physical health and organ function are suitable for major abdominal surgery.
  • People whose blood test results meet minimum levels for red blood cells, white blood cells, and platelets, and whose liver and kidney function tests fall within required ranges (confirm with trial site for exact values).
  • People whose heart function meets specific requirements, including a healthy pumping ability, no signs of reduced blood flow to the heart on an ECG, and no history of irregular heartbeat requiring medication.
  • People who do not have any serious ongoing illness that would be expected to shorten life expectancy to less than 5 years.
  • People who are willing and able to follow the study procedures throughout the trial period.
  • People who provide written consent before the study begins.

Who may not be able to join:

  • People who have already received chemotherapy, radiotherapy, or immunotherapy for this stomach cancer.
  • People who are pregnant or breastfeeding.
  • People of childbearing potential who test positive for pregnancy at the start of the study, or who have not had a pregnancy test; women must have been in menopause for at least 12 months to be considered unable to become pregnant.
  • People who are sexually active and able to have children but are unwilling to use contraception during the study.
  • People who have a large amount of fluid in the abdomen and cancer cells detected in that fluid.
  • People who have had another type of cancer in the last 5 years, except for certain fully treated skin cancers or early-stage cervical cancer.
  • People with a history of epilepsy, nervous system disease, or a mental health condition that the trial doctor believes may affect their ability to consent or to take medication as required.
  • People with significant active heart disease, such as symptomatic coronary heart disease, moderate-to-severe heart failure, serious irregular heartbeat requiring medical treatment, or a heart attack within the past 12 months.
  • People who have a specific enzyme deficiency (dihydropyrimidine dehydrogenase deficiency) that affects how certain chemotherapy drugs are broken down in the body.
  • People with nerve damage in their hands or feet that reaches a certain level of severity on a standard medical grading scale (confirm with trial site).
  • People who have had an organ transplant and require medication to suppress their immune system.
  • People with severe, uncontrolled or recurring infections, or other serious uncontrolled medical conditions.
  • People with moderate or severe kidney impairment, based on specific kidney function measurements (confirm with trial site for exact thresholds).
  • People with active hepatitis B or hepatitis C infection, or specific blood test results indicating high levels of hepatitis B or C virus activity, or a combination of certain positive hepatitis markers.
  • People who are allergic to any ingredient in the study drugs.
  • People who have participated in another clinical trial within the 4 weeks before joining this study.
  • People the trial doctor considers unsuitable for any other reason.

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 12 July 2026
Phase 2: approximately ~30% 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: Qi Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Phone: 13818207333

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 2
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Registry
ClinicalTrials.gov
Start date
5 September 2022
Est. completion
30 September 2023

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Pathological complete remission 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: 12 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