Phase 2 Colorectal Cancer Trial, Recruiting NCT07718490 Sponsor: The First Affiliated Hospital with Nanjing Medical University Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT07718490
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 and willing to give written consent to take part in the study voluntarily.
  • People aged between 18 and 75 years old (inclusive), of any gender.
  • People whose colorectal cancer has spread to other parts of the body (metastatic), confirmed by a laboratory test on a tissue or cell sample.
  • People who have not previously had systemic (whole-body) anti-cancer treatment — or, if they received chemotherapy before or after surgery, their cancer did not return or worsen until more than 6 months after that treatment ended.
  • People whose general health and ability to carry out daily activities is rated as fully active or restricted only in physically strenuous activity (ECOG score of 0 or 1).
  • People whose life expectancy is at least 3 months.
  • People who have at least one measurable tumour that has not previously been treated with radiation or other local therapy (unless that tumour has since been confirmed to have grown back or worsened).
  • People whose blood and organ function meets the required levels, including acceptable counts for white blood cells, platelets, and haemoglobin; adequate liver, kidney, and clotting function; and sufficient protein levels in the blood — assessed without the use of blood products or growth factor medicines in the 14 days before starting the study.
  • Women of childbearing age who have a negative pregnancy test within 72 hours before starting the study, are not breastfeeding, and agree to use effective contraception during the study and for at least 6 months after the last dose.
  • Men with partners who could become pregnant who either have had a sterilisation procedure or agree to use effective contraception during the study and for 3 months after the last dose, and agree not to donate sperm during the study period.

Who may not be able to join:

  • People who received radiation therapy to a large area of the body within the 4 weeks before starting the study, and who have not yet recovered from side effects of that radiation.
  • People with active cancer that has spread to the brain or the lining around the brain (carcinomatous meningitis). People with previously treated and stable brain metastases may still be considered, as long as they have not needed steroid treatment for this for at least 28 days before entering the study — however, carcinomatous meningitis is excluded in all cases.
  • People who had major surgery, a large biopsy, or a serious injury within 28 days before starting the study.
  • People with a known allergy to anti-angiogenic medicines, components of monoclonal antibody drugs, or the chemotherapy medicines used in the trial (capecitabine, oxaliplatin, or similar platinum-based drugs).
  • People with high blood pressure that remains uncontrolled despite taking blood pressure medication (readings at or above 140/90 mmHg).
  • People with serious heart conditions, including moderate-to-severe heart failure, unstable chest pain (angina), a heart attack within the past year, or significant irregular heart rhythms that are not well controlled.
  • People who have had significant bleeding or a clear tendency to bleed within the 3 months before starting the study (for example, gastrointestinal bleeding, bleeding stomach ulcers, or blood vessel inflammation).
  • People who have had a blood clot event within the 6 months before starting the study — such as a stroke, mini-stroke, brain bleed, deep vein thrombosis, or pulmonary embolism (clot in the lungs). Cases of superficial (surface-level) vein clots may be considered at the trial doctor's discretion.
  • People currently being treated for another active cancer, except for certain skin cancers or early-stage cervical cancer that have already been fully treated.
  • People who, in the opinion of the investigator, have other circumstances that could interfere with their safety or ability to complete the study — such as serious other illnesses (including mental health conditions), significant abnormal lab results, or personal or social factors that could affect their wellbeing or the reliability of trial data.

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 23 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 25 6830 6714

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
31 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Investigator-assessed Objective Response Rate(ORR)

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: 23 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