Phase 1 Colorectal Cancer Trial, Recruiting NCT07035002 Sponsor: Ruijin Hospital Condition: Colorectal Cancer
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Phase 1 Colorectal Cancer Trial, Recruiting

NCT07035002
Recruiting Phase 1

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 been diagnosed with advanced colorectal cancer, confirmed by a lab test on tissue or cell samples, and who are no longer able to receive standard treatments.
  • People who are willing to have surgery or a biopsy to collect tumor tissue, which will be used to prepare the treatment used in this trial.
  • People aged 18 to 70 years old.
  • People who have at least one tumor that can be measured using standard imaging guidelines (called RECIST 1.1).
  • People who are generally well enough to carry out light activity or desk work — rated 0 or 1 on a standard health performance scale (ECOG).
  • People whose bone marrow, liver, kidneys, and other organs are working well enough to meet the trial's health requirements.
  • People whose doctors estimate they are likely to live for at least 6 more months.

Who may not be able to join:

  • People who received chemotherapy, radiation, biological therapy, hormone therapy, immunotherapy, or certain traditional Chinese medicine anti-cancer treatments within 2 weeks before the tissue sample is collected (with some specific exceptions — confirm with trial site).
  • People who took part in another trial using an unapproved or experimental treatment within 4 weeks before the tissue sample is collected.
  • People who had major surgery (not counting needle biopsies) within 4 weeks before the tissue sample is collected, had a serious injury, or who need planned surgery during the trial period.
  • People who have taken high-dose steroid medications by mouth or injection (such as prednisone above a certain dose) within 14 days before the tissue sample is collected, to suppress the immune system (some forms of steroids used locally, such as eye drops, joint injections, or inhalers, may be exceptions — confirm with trial site).
  • People who used certain immune-boosting medicines, such as thymosin, interleukin-2, or interferon, within 14 days before the tissue sample is collected.
  • People who received a live vaccine within 4 weeks before the tissue sample is collected.
  • People who still have side effects from previous cancer treatments that have not improved to a mild level (with some exceptions, such as hair loss — confirm with trial site).
  • People who have cancer that has spread to the brain or the lining around the brain, and where those symptoms are active or not well controlled.
  • People who have an active infection requiring ongoing antibiotic or antiviral treatment within 1 week before the tissue sample is collected.
  • People who have a history of immune system deficiency, or who test positive for HIV.
  • People who test positive for Hepatitis B, Hepatitis C, or syphilis.
  • People who currently have a lung condition called interstitial lung disease.
  • People with a serious history of heart or blood vessel disease, including certain irregular heart rhythms, recent heart attack, heart failure, stroke, aortic dissection, or other serious cardiac events within the past 6 months; uncontrolled high blood pressure; or significant structural heart problems (confirm details with trial site).
  • People with active or past autoimmune diseases (such as lupus, rheumatoid arthritis, or vasculitis), with some possible exceptions for people with stable thyroid autoimmune conditions or well-managed type 1 diabetes (confirm with trial site).
  • People who previously had a serious immune-related side effect (grade 3 or higher) from immunotherapy.
  • People who have uncontrolled fluid build-up in body cavities (such as around the lungs or abdomen), which the trial doctor judges to be a safety concern.
  • People with a known dependence on alcohol or drugs.
  • People with mental health conditions or who are unlikely to be able to follow the trial requirements.
  • People who are pregnant or breastfeeding.

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 21 July 2026
Phase 1: approximately ~10% 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.

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Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
31 December 2024
Est. completion
1 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Tolerance as the highest dose without side effects; Safety as severe treatment related complications

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: 21 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