Stomach Cancer Trial, Recruiting NCT06158919 Sponsor: Fudan University Condition: Stomach Cancer
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Stomach Cancer Trial, Recruiting

NCT06158919
Recruiting Not Applicable

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 who have fully understood the study and have signed a consent form agreeing to take part voluntarily
  • People aged 18 to 80 years old (inclusive), of any gender
  • People who have been confirmed by pathology or tissue testing to have advanced or metastatic stomach cancer or cancer at the junction of the esophagus and stomach that cannot be removed by surgery
  • People with a good general level of physical function (rated 0 or 1 on a standard medical scale, meaning able to carry out normal daily activities with little or no restriction)
  • People whose doctors expect them to live for at least 3 months
  • People who have not previously received any anti-cancer treatment (such as chemotherapy, targeted therapy, or immunotherapy) for their advanced or metastatic stomach cancer — or, if they did receive preventive treatment after earlier stomach surgery, at least 6 months must have passed between when the cancer spread returning was discovered and when that earlier treatment ended
  • People who have at least one tumour that can be measured on a scan, according to standard criteria
  • People whose blood counts, organ function, and heart function meet specific laboratory thresholds set by the trial (confirm exact values with the trial site)
  • Women who have not yet reached menopause, or who have been post-menopausal for less than one year, must have a negative pregnancy test before treatment begins

Who may not be able to join:

  • People whose stomach cancer is known to be HER-2 positive (a specific protein found on some cancer cells, confirmed by certain laboratory tests)
  • People who have had another type of cancer in the past 5 years, except for certain skin cancers or cervical pre-cancer that were fully treated with surgery
  • People who have previously had a bone marrow transplant or an organ transplant from another person
  • People who have had serious heart problems, such as unstable chest pain or a heart attack, in the 6 months before joining
  • People who are known to be allergic to the study drug or any of its ingredients
  • People with high blood pressure that cannot be controlled with medication (specifically, blood pressure readings at or above 150/90 mmHg)
  • People who have a condition that affects how the body absorbs medicine, or who are unable to swallow tablets or capsules
  • People with certain active stomach or bowel conditions, such as active ulcers, ulcerative colitis, active bleeding from a tumour, or other conditions that could cause serious bowel bleeding or perforation
  • People who have had significant bleeding in the past 3 months, have coughed up fresh blood recently, or have had a blood clot, stroke, or mini-stroke in the past 12 months
  • People with significant heart conditions, including recent heart attack, severe chest pain, recent heart bypass surgery, moderate-to-severe heart failure, certain irregular heart rhythms, or a heart pumping function below 50%
  • People with an active or uncontrolled serious infection
  • People known to have HIV infection, active hepatitis B, or active hepatitis C
  • People who have an active autoimmune disease or a history of certain autoimmune conditions (some exceptions may apply — confirm with the trial site)
  • People who have used immune-suppressing medications or high-dose steroid medicines within the 7 days before joining
  • People currently experiencing lung conditions such as interstitial lung disease, lung inflammation, pulmonary fibrosis, or radiation-related lung damage
  • Women who are pregnant or breastfeeding
  • People with significant protein detected in their urine above a certain level
  • People with any other medical condition, abnormal test result, or physical finding that the trial doctors consider would make participation unsafe or affect the trial results

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Xiaodong Zhu, Fudan University

Phone: 18017312567

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
20 November 2023
Est. completion
20 November 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

PFS

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