Phase 1 Colorectal Cancer Trial, Recruiting NCT07247396 Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Condition: Colorectal Cancer
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Phase 1 Colorectal Cancer Trial, Recruiting

NCT07247396
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 aged 18 to 75 years old at the time of signing the consent form
  • People who have been diagnosed with colorectal cancer that has spread to the lining of the abdomen (called peritoneal metastases), confirmed by laboratory testing
  • People whose cancer has stopped responding to standard treatments (such as oxaliplatin, irinotecan, or fluorouracil), or who could not tolerate those treatments, or for whom no effective treatment options remain
  • People who have already had surgery to remove as much of the abdominal tumour spread as possible, recovered well without serious complications, and whose scans show the cancer has not spread to other organs such as the liver, lungs, bones, or brain
  • People whose tumour tissue from that surgery tested positive for a protein called CEA (found in at least 10% of tumour cells on laboratory staining)
  • People whose cancer spread is limited to the abdominal lining only, with no spread to other parts of the body, and whose original bowel tumour has been removed
  • People expected to live for at least 3 months
  • People with a good general level of physical functioning (able to carry out normal daily activities with little or no restriction, as scored by a standard medical scale)
  • People whose blood counts, heart function, kidney function, liver function, and blood oxygen levels all fall within acceptable ranges as measured by tests
  • Women who could become pregnant must have a negative pregnancy test within 7 days before joining, have no immediate plans for pregnancy, and agree to use contraception during the trial
  • Men must agree to use appropriate contraception during the trial
  • People who are willing and able to follow the study procedures and attend follow-up appointments

Who may not be able to join:

  • People who are not willing to sign the consent form
  • People who have received anti-cancer drug treatment within the 2 weeks before joining (except for heated chemotherapy delivered directly into the abdomen during surgery)
  • People with an active or uncontrolled infection (bacterial, fungal, or viral) confirmed by a doctor
  • People who have another active cancer that has not been cured, except for certain early-stage or localised skin or cervical conditions (confirm with trial site)
  • People with a history of severe asthma, an active autoimmune disease, a weakened immune system, or those who need long-term immune-suppressing medication — though some specific conditions such as vitiligo, type 1 diabetes, thyroid conditions managed with hormones, or mild psoriasis may be considered exceptions (confirm with trial site)
  • People with a history of mental illness
  • People with serious uncontrolled heart or blood vessel conditions, such as heart failure, unstable chest pain, irregular heartbeat, or severe coronary or stroke-related disease
  • People who test positive for active hepatitis B, active hepatitis C, HIV, or syphilis
  • People with a known allergy or sensitivity to any ingredient in the study treatment, or those the doctor considers at risk of a reaction to immunotherapy
  • Women who are pregnant or breastfeeding
  • People who the doctor believes have other serious illnesses that may affect their follow-up or short-term health
  • People considered ineligible for other reasons, as determined by the treating doctor

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 16 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.

Contact this trial

Principal Investigator: Lifeng Sun, Second Affiliated Hospital, School of Medicine, Zhejiang University

Phone: 0571-87783583

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 1
Registry
ClinicalTrials.gov
Start date
3 November 2025
Est. completion
31 May 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

To evaluate the safety of CAR-T cell preparations in the treatment of advanced colorectal cancer with peritoneal metastases following cytoreductive surgery [Safety and Tolerability]; Obtained the recommended dose of CAR-T cells for the treatment of advanced colorectal cancer with peritoneal metastases following cytoreductive surgery [Safety and Tolerability]

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: 16 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