Phase 2 Colorectal Cancer Trial, Recruiting NCT06385418 Sponsor: The Second Hospital of Nanjing Medical University Condition: Colorectal Cancer
Back to Colorectal Cancer

Phase 2 Colorectal Cancer Trial, Recruiting

NCT06385418
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 of Chinese ethnicity aged between 18 and 75 years, male or female
  • People who have been diagnosed with colorectal cancer confirmed by a tissue biopsy, with a measurable tumour as assessed by standard imaging criteria
  • People whose general physical fitness and ability to carry out daily activities meets a certain level (confirm with trial site)
  • People whose doctors estimate they are likely to live for more than 3 months
  • People for whom a multidisciplinary medical team has agreed that adding a local chemotherapy approach to their existing cancer treatment plan is appropriate
  • People whose blood counts, liver function, kidney function, and heart function all meet specific minimum levels set by the trial (confirm with trial site for exact values)
  • Women of childbearing age who have a negative pregnancy test within 7 days before joining, and sexually active participants who agree to use appropriate contraception during the trial and for 8 weeks after the last dose of the study treatment
  • People who are in suitable physical condition and willing to undergo a specific procedure involving a tube placed into the colon via a camera examination
  • People who are willing to attend regular follow-up appointments and tests as recommended after treatment
  • People who agree to have tissue or fluid samples collected and who sign a written consent form

Who may not be able to join:

  • People with uncontrolled heart conditions — such as severe heart failure, coronary artery disease, irregular heart rhythms, or unstable circulation — that could pose a significant risk during treatment
  • People with active, serious infections (including fungal, viral, or tuberculosis infections, particularly in the digestive tract) that are not well controlled
  • People with blood clotting problems or a tendency to bleed, or those taking blood-thinning medications such as warfarin or heparin, unless their clotting levels fall within an acceptable range — low-dose warfarin or low-dose aspirin for prevention may be allowed (confirm with trial site)
  • People with a known immune system deficiency, another condition that weakens the immune system, or a history of organ transplantation
  • People who have another cancer that is currently growing or being actively treated, except for certain minor skin cancers or early-stage cervical changes that have been adequately treated
  • People with other serious health conditions that the treating doctor considers would make participation unsafe or unsuitable
  • Women who are currently breastfeeding
  • People with a known allergy or intolerance to the study drug or any of its ingredients
  • People who have participated in another drug clinical trial within the past four weeks
  • People who do not have the legal capacity to consent for themselves

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

Principal Investigator: Faming Zhang, MD, PhD, Department of Microbiota Medicine & Medical Center for Digestive Diseases

Phone: 86-025-58509883

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
The Second Hospital of Nanjing Medical University
Registry
ClinicalTrials.gov
Start date
16 May 2024
Est. completion
1 May 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective response rate (according to RECIST1.1, investigator assessment)

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