Clinical Trials Logo
  1. Home
  2. Colorectal Neoplasms Malignant
  3. NCT05279677

FMT Combined With Immune Checkpoint Inhibitor and TKI in the Treatment of CRC Patients With Advanced Stage

Colorectal Neoplasms Malignant Clinical Trial

Official title:
Phase II, Single-arm Study of FMT Combined With Immune Checkpoint Inhibitor and TKI in the Treatment of Colorectal Cancer Patients With Advanced Stage

Clinical Trial Summary

A single-arm, phase II study was designed to evaluate the efficacy and safety of fecal microbiota transplantation plus Sintilimab and Fruquintinib as the later line treatment in colorectal patients with advanced stages.

Clinical Trial Description

The combination of regorafenib plus nivolumab had already presented a manageable safety profile and encouraging antitumor activity in patients with mCRC as the REGONIVO trail reported. While additional investigations showed limited ORRs between 7%-33% as third or later line treatement in mCRC. Gut microbiota modulation, with the aim to reverse established microbial dysbiosis, is a novel strategy for the treatment of CRC. The individualized gut microbiome transplantation may further imrpove the efficacy of the combination therapy of CPI and TKI. Thus, a single-arm, phase II study was designed to evaluate the efficacy and safety of FMT plus Sintilimab and Fruquintinib as the later line treatment in CRC patients with advanced stages. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05279677
Study type Interventional
Source Chinese Academy of Medical Sciences
Contact Aiping Zhou, MD
Phone 86 13691161998
Email zhouap1825@126.com
Status Recruiting
Phase Phase 2
Start date August 12, 2022
Completion date April 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04712292 - Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer
Active, not recruiting NCT03775980 - CIRSE Emprint Microwave Ablation Registry
Recruiting NCT05155124 - Safety of Cetuximab and Trifluridin Tipiracil as the Third-line Therapy in the RASwt mCRC Phase 1
Recruiting NCT06050447 - Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Active, not recruiting NCT03993626 - A Trial of CXD101 in Combination With Nivolumab in Patients With Metastatic Microsatellite-Stable Colorectal Cancer Phase 1/Phase 2
Recruiting NCT06314971 - Predicting Local and Distant Recurrence in T1 Colorectal Cancer
Recruiting NCT06342440 - Early Detection of Advanced Adenomas and Colorectal Cancer
Recruiting NCT05853094 - Postoperative Effects of Different Enterostomy Approaches N/A
Recruiting NCT06200831 - Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases N/A
Recruiting NCT02758951 - Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases Phase 2/Phase 3
Recruiting NCT03686254 - The Effects of RFA in Combination With Second-line Chemotherapy and Bevacizumab on Unresectable CRLM Phase 2/Phase 3
Recruiting NCT05278351 - Tislelizumab Plus Cetuximab and Irinotecan vs Third-line Standard-of-care in Refractory mCRC Phase 2
Terminated NCT04873895 - TACE Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Colorectal Cancer (CRC) Phase 1
Completed NCT04002128 - Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery N/A
Recruiting NCT06208371 - Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM Phase 3
Not yet recruiting NCT05129774 - Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM N/A
Completed NCT06410729 - Significance of Benign Lymph Node Enlargement in Colorectal Cancer
Completed NCT03507699 - Combined Immunotherapy and Radiosurgery for Metastatic Colorectal Cancer Phase 1
Active, not recruiting NCT03581890 - Socioeconomic Position in Acute Colorectal Cancer Surgery
Recruiting NCT05138094 - LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection N/A