Phase 2 Colorectal Cancer Trial, Recruiting NCT06881537 Sponsor: Shanghai Changzheng Hospital Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT06881537
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:

  • You had colorectal cancer that was surgically removed (with all cancer tissue fully removed), confirmed by lab testing to be a specific type called adenocarcinoma, and you received standard chemotherapy after surgery.
  • Your cancer has come back in the same local area, confirmed by imaging scans and tissue testing.
  • You have not received any cancer treatment (chemotherapy, targeted therapy, immunotherapy, or radiation) in the past month.
  • Your cancer can be measured on imaging scans according to standard medical guidelines.
  • You are generally active and able to carry out daily activities with little or no restriction (confirm with trial site).
  • Scans (CT, MRI, or PET/CT) have confirmed that the cancer has not spread to distant parts of the body.
  • Your blood counts, kidney function, liver function, and blood clotting results meet specific healthy ranges, tested within 7 days before starting the trial.
  • If you are a woman who could become pregnant, you have tested negative for pregnancy and agree to use effective birth control during treatment and for 60 days afterward.
  • Your doctor expects you to live for more than 3 months.
  • You are willing and able to sign a consent form agreeing to take part.

Who may not be able to join:

  • You have previously been treated with certain immunotherapy drugs that target PD-1, PD-L1, PD-L2, or CTLA-4.
  • Your tumor is causing a blockage in your bowel or uncontrolled bleeding that needs urgent treatment.
  • You have a known medical reason why you cannot take any of the trial drugs: Oxaliplatin, Capecitabine, Bevacizumab, or Tislelizumab.
  • You have had a serious allergic reaction to other similar antibody-based medicines.
  • You have any active or suspected condition where your immune system attacks your own body (autoimmune disease).
  • You have uncontrolled fluid build-up around your lungs, heart, or in your abdomen.
  • You have a history of certain lung conditions, such as pulmonary fibrosis, drug-related lung inflammation, or other forms of lung scarring or inflammation, or currently have active pneumonia shown on scans.
  • You had major surgery within the 4 weeks before joining and have not fully recovered.
  • You have active bleeding, abnormal blood clotting results, a tendency to bleed, or are receiving blood-thinning or clot-dissolving treatments.
  • You have previously had a stem cell transplant or an organ transplant from another person.
  • You have significant uncontrolled health conditions such as uncontrolled infection, uncontrolled diabetes, high blood pressure not controlled by one medication, significant nerve damage in hands or feet, heart failure, a heart attack within the past 3 months, unstable heart rhythm, unstable chest pain, chronic kidney disease, thyroid problems, or a history of another cancer.
  • You have a history of uncorrected imbalances in important minerals in your blood, such as potassium, calcium, or magnesium.
  • You are HIV positive.
  • You have active hepatitis B or hepatitis C infection.
  • You are pregnant, breastfeeding, or unwilling to use contraception during the trial.
  • You have had another cancer in the past 5 years, with some exceptions such as certain early-stage or skin cancers (confirm with trial site).
  • You have taken steroid medications above a low dose, or other medicines that suppress the immune system, within the past 14 days.
  • You have active tuberculosis (TB) or have received TB treatment within the past year.
  • You have an active infection or have taken antibiotic tablets or injections in the 2 weeks before starting treatment (unless taken as a preventive measure).
  • You have received a live vaccine (such as flu or chickenpox vaccine) within 4 weeks before starting the trial.
  • You have taken part in another clinical trial within 4 weeks before joining this one.
  • You have any other significant health condition, abnormal test result, or other concern that the trial team believes could make participation unsafe or affect the reliability of the 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 27 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

Phone: +86 81885615

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 Changzheng Hospital
Registry
ClinicalTrials.gov
Start date
1 June 2024
Est. completion
30 June 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective response rate; R0 resection rate; Pathological complete response rate; Tumor regression grade (TRG); Incidence of Treatment-Related Adverse Events

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: 27 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