Phase 2 Colorectal Cancer Trial, Recruiting NCT06718543 Sponsor: fan li Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT06718543
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 have signed a consent form agreeing to take part in the study.
  • You are between 18 and 80 years old, of any gender.
  • Your doctors have confirmed through a tissue sample (biopsy) that you have rectal cancer (a specific type called adenocarcinoma).
  • Your cancer is at a certain stage, confirmed by an MRI scan, meaning it has grown into or beyond the rectal wall and/or spread to nearby lymph nodes, but has not spread to distant parts of the body.
  • You are able to swallow tablets.
  • You are generally well enough to carry out daily activities with little or no limitation (confirm with trial site).
  • You have not received any previous treatment for your rectal cancer, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
  • You are healthy enough to have surgery with no medical reasons preventing it.
  • Your organs (such as liver, kidneys, and heart) are functioning normally.
  • Your tumour is located no more than 12 cm from the opening of the back passage (anus).

Who may not be able to join:

  • You have a known allergy to monoclonal antibodies or to any of the specific drugs used in this trial (AK112 or the CapeOX chemotherapy regimen).
  • You have previously used or are currently using immune checkpoint inhibitor drugs or similar immune-based treatments.
  • You have an active autoimmune disease or a significant history of autoimmune conditions (where the immune system attacks the body).
  • You have an immune system disorder, or you have previously had an organ or bone marrow transplant.
  • You have heart or cardiovascular problems that are not well controlled, such as heart failure, unstable chest pain (angina), or a recent heart attack.
  • You have had a serious infection in the last 4 weeks, or you currently have an active lung infection.
  • You currently have an active hepatitis B or hepatitis C infection.
  • You have been diagnosed with another cancer within the last 5 years (with some exceptions for certain low-risk cancers — confirm with trial site).
  • You are currently 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 8 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: +8618696539200

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
fan li
Registry
ClinicalTrials.gov
Start date
10 February 2025
Est. completion
31 October 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Complete Response 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: 8 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