Phase 3 Colorectal Cancer Trial, Recruiting NCT06951503 Sponsor: Akeso Condition: Colorectal Cancer
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Phase 3 Colorectal Cancer Trial, Recruiting

NCT06951503
Recruiting Phase 3

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 given their written consent to participate
  • People aged 18 to 75 years old
  • People who are generally well enough to carry out light activity and care for themselves (a doctor assesses this using a standard scale called ECOG, with a score of 0 or 1)
  • People whose doctors estimate they are likely to live for at least 3 more months
  • People who have been diagnosed with colorectal cancer (a type of bowel cancer) that has spread to other parts of the body, confirmed through a tissue or cell sample
  • People whose cancer cannot be fully removed by surgery or treated locally, and who have not yet received systemic (whole-body) anti-cancer treatment for their cancer after it returned or spread — although people who had earlier preventive treatment (before or after surgery) may be eligible if their cancer came back more than 12 months after that treatment ended
  • People who have at least one area of cancer that can be measured on scans, according to standard guidelines
  • People whose liver, kidneys, heart, and other organs are functioning well enough to meet the trial's requirements
  • Women who could become pregnant, and men whose female partners could become pregnant, who agree to use effective contraception throughout treatment and for at least 180 days after the last dose of the trial treatment

Who may not be able to join:

  • People who have had another type of cancer within the past 3 years, or who currently have another cancer (unless it has been fully cured)
  • People who have taken part in another clinical intervention trial within the 4 weeks before starting this trial
  • People who received local treatment aimed at relieving symptoms (not curing) within 2 weeks before the first dose, or who received certain immune-boosting therapies within 2 weeks before the first dose
  • People who have another serious illness that is not currently under control
  • People who have an active infection at the time of enrolment
  • People with a history of serious bleeding problems or blood clotting disorders
  • People with known active tuberculosis (TB) or active syphilis infection (suspected TB would need to be ruled out by a doctor before joining)
  • People who received a live vaccine within 30 days before the trial starts, or who plan to receive one during the trial
  • People who have significant bowel blockage (obstruction) confirmed by scans or symptoms
  • People who still have side effects from previous cancer treatment that have not improved to a mild level (Grade 1 or lower, based on a standard medical scale)
  • Women who are pregnant or breastfeeding
  • People with a non-cancer-related condition that could increase medical risk or make it harder to predict survival outcomes
  • People whom the trial doctor considers unsuitable 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 28 July 2026
Phase 3: approximately ~65% 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(0760)89873999

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 3
Sponsor
Akeso
Registry
ClinicalTrials.gov
Start date
27 May 2025
Est. completion
13 January 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Progression-free survival (PFS) assessed by blinded independent central review (BICR)

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: 28 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