Phase 2 Colorectal Cancer Trial, Recruiting NCT07561060 Sponsor: Fudan University Condition: Colorectal Cancer
Back to Colorectal Cancer

Phase 2 Colorectal Cancer Trial, Recruiting

NCT07561060
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 who are able to give written consent and are willing to follow the trial schedule and requirements
  • People aged 18 to 75 years old
  • People who have been diagnosed with rectal adenocarcinoma (a specific type of rectal cancer), confirmed through laboratory testing of tissue
  • People whose cancer has been tested and shown to have a specific molecular profile (known as pMMR, MSI-L, or MSS) through laboratory methods (confirm with trial site)
  • People whose tumor is located within 3 cm of a specific part of the lower bowel (the dentate line), as confirmed by colonoscopy, physical examination, or MRI scan
  • People whose cancer is at an early-to-moderate stage (cT1–3, N0–1, M0) as assessed by MRI, meaning it has not spread to distant parts of the body
  • People whose tumor has been assessed by the trial doctor as able to be surgically removed
  • People who have not yet received any treatment for their rectal cancer
  • People who are generally well enough to carry out daily activities with little or no limitation (confirmed by a standard medical performance scale)
  • People whose organ function (such as liver, kidneys, and blood) meets the required levels
  • Women who could become pregnant must have a negative pregnancy blood test within 72 hours before starting the trial, and must agree to use highly effective contraception during the trial and for 120 days after the last dose; men whose partners could become pregnant must either have had a sterilisation procedure or agree to use highly effective contraception during the trial and for 120 days after the last dose

Who may not be able to join:

  • People whose rectal cancer is confirmed as a poorly differentiated, undifferentiated, mucinous, or signet ring cell type of adenocarcinoma
  • People who have already received treatment for rectal cancer, or whose cancer has spread to other parts of the body
  • People whose MRI scan shows certain high-risk features, including involvement of the surrounding tissue boundary, spread into nearby blood or lymph vessels, more advanced lymph node involvement, positive lateral lymph nodes, or a deeper level of tumour spread into surrounding fat (confirm with trial site for specific terms)
  • People who have, or are at high risk of, a blockage, tear, or bleeding in the bowel
  • People for whom long-course radiotherapy is not medically appropriate
  • People who are not well enough to undergo surgery
  • People who have two or more colorectal cancer tumours at the same time
  • People who cannot have an MRI scan for any reason
  • People who have had, or currently have, another type of cancer
  • People who have an active autoimmune disease that has required ongoing medical treatment within the past 2 years
  • People who have HIV infection
  • People who have untreated chronic hepatitis B, or carry the hepatitis B virus with levels above a certain threshold, or have active hepatitis C with detectable virus in the blood
  • People who have a known allergy or sensitivity to any of the trial medicines (tislelizumab, capecitabine, or oxaliplatin) or their components
  • People who, in the trial doctor's judgement, do not meet the trial requirements 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 9 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: +862164041990

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
Registry
ClinicalTrials.gov
Start date
1 January 2024
Est. completion
1 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Complete Response rate (CR 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: 9 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