Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07319364

A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-01-06

90

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy / targeted gastrointestinal symptoms. The main question it aims to answer is: To evaluate the effect of fecal microbiota transplantation (FMT) on gastrointestinal tract in patients with gastrointestinal tumors.

CONDITIONS

Official Title

A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Estimated survival time of 3 months or more
  • Confirmed diagnosis of gastrointestinal tumors by pathology, including esophageal, gastric, colon, or rectal cancer
  • Cancer at Stage IV according to TNM staging
  • Completed PD-1 or PD-L1 testing
  • Planned to receive the 4th cycle of chemotherapy or targeted therapy
  • Experienced gastrointestinal side effects such as diarrhea, constipation, vomiting, or nausea within the first 3 cycles of chemotherapy or targeted therapy
  • Able and willing to provide informed consent and complete follow-up
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 1 to 3
  • Use of broad-spectrum antibiotics within 3 days should be cautious
  • Able to swallow capsules without chewing
  • Laboratory tests during screening show adequate organ function
Not Eligible

You will not qualify if you...

  • Major organ dysfunction or failure including heart, kidney, or liver problems
  • Uncontrolled or severe infections
  • History of psychotropic substance abuse, alcoholism, or drug abuse
  • Severe infections with septicemia or sepsis
  • History of severe allergic reactions or allergy to components of bacterial capsules
  • Active viral infections
  • Positive pregnancy test, lactating women, or women of childbearing age not using contraception during the 15-week observation period
  • Gastrointestinal perforation or fistula
  • Any other conditions the investigator considers unsuitable for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital Zhejiang University School of Medicine

Zhejiang, Hangzhou, China, 310009

Actively Recruiting

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Research Team

D

Da Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects | DecenTrialz