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NCT04866862

Fruquitinib Combined With Camrelizumab in Non MSI-H/dMMR Refractory Colorectal Cancer

Status unknown Phase 2 Last updated 25 July 2022
What this trial tests

Phase 2 trial testing Combination of Fruquintinib and Camrelizumab in Colorectal Neoplasm in 32 participants. Status unknown.

Timeline
26 April 2021
Primary endpoint
1 June 2024
1 June 2024

Quick facts

Lead sponsorThe First Affiliated Hospital with Nanjing Medical University
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment32
Start date26 April 2021
Primary completion1 June 2024
Estimated completion1 June 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

Adults 18 to 70, any sex, with Colorectal Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Limited agents are optional after standard first and second line treatment for mCRC. Nowadays, cancer therapy has entered the era of immunotherapy. The approved cancer therapies include pembrolizumab and nivolumab, but only for MSI-H patients. 95% of non MSI-H / dMMR patients with advanced colorectal cancer can not benefit from them. Therefore, the use of PD-1 / PD-L1 monoclonal antibody in mCRC is greatly limited. Our previous research showed that anti-PD-1 combined with Fruquintinib can significantly inhibit the growth of CRC in MSS mice. At the same time, a retrospective clinical study showed that patients with MSS CRC can benefit from Sintilimab combined with Fruquintinib. Camrelizumab is PD-1 monoclonal antibody, which has been approved for a variety of tumors. The prospective clinical trial of Camrelizumab combined with Fruquintinib may bring new hope for the treatment of non MSI-H / dMMR patients with mCRC.This study is aimed to explore the efficacy, safety in advanced colorectal cancer failed to standard therapy in Chinese population.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunosuppressive tumor microenvironment modulation by chemotherapies and targeted therapies to enhance immunotherapy effectiveness.
    Barnestein R, Galland L, Kalfeist L, Ghiringhelli F, et al · · 2022 · cited 66× · PMID 36117524 · DOI 10.1080/2162402x.2022.2120676
  2. Molecular mechanisms targeting drug-resistance and metastasis in colorectal cancer: Updates and beyond.
    Al Bitar S, El-Sabban M, Doughan S, Abou-Kheir W. · · 2023 · cited 53× · PMID 36998426 · DOI 10.3748/wjg.v29.i9.1395
  3. Biomarkers of Response and Resistance to Immunotherapy in Microsatellite Stable Colorectal Cancer: Toward a New Personalized Medicine.
    Huyghe N, Benidovskaya E, Stevens P, Van den Eynde M. · · 2022 · cited 36× · PMID 35565369 · DOI 10.3390/cancers14092241
  4. Microsatellite Instability: From the Implementation of the Detection to a Prognostic and Predictive Role in Cancers.
    Amato M, Franco R, Facchini G, Addeo R, et al · · 2022 · cited 32× · PMID 35955855 · DOI 10.3390/ijms23158726
  5. The role of immunotherapy in microsatellites stable metastatic colorectal cancer: state of the art and future perspectives.
    Gandini A, Puglisi S, Pirrone C, Martelli V, et al · · 2023 · cited 29× · PMID 37207140 · DOI 10.3389/fonc.2023.1161048
  6. Evaluation of Fruquintinib in the Continuum of Care of Patients with Colorectal Cancer.
    Lavacchi D, Roviello G, Guidolin A, Romano S, et al · · 2023 · cited 10× · PMID 36982913 · DOI 10.3390/ijms24065840
  7. The Interplay between Anti-Angiogenics and Immunotherapy in Colorectal Cancer.
    Maiorano BA, Parisi A, Maiello E, Ciardiello D. · · 2022 · cited 7× · PMID 36294987 · DOI 10.3390/life12101552
  8. The Current Role of Antiangiogenics in Colorectal Cancer.
    Basile D, Di Nardo P, Daffinà MG, Cortese C, et al · · 2025 · PMID 41373757 · DOI 10.3390/ijms262311605

Verify or expand the search:

Other recruiting trials for Colorectal Neoplasm

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