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Clinical trial · no report yet · Phase 3

FRESCO-2

A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer

  • NCT04322539 ↗
  • Completed
  • Hutchison Medipharma Limited
  • 131 commentary sources found
  • Deep

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
Podcasts54
X threads46
YouTube30
X videos1

The trial

ClinicalTrials.gov
Official title
A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer
Phase
Phase 3
Status
Completed
Conditions
Metastatic Colorectal Cancer; Metastatic Colon Cancer
Interventions
Fruquintinib; Placebo
Arms
  • Fruquintinib Plus Best Supportive Care (BSC) Group · Experimental
  • Placebo Plus BSC Group · Placebo comparator
Enrollment
691
Primary outcomes
  • Overall Survival (OS)
Sponsor
Hutchison Medipharma Limited
Start
Aug 12, 2020
Primary completion
Jul 29, 2022
Results posted
Yes
Registry record
NCT04322539 · updated Apr 4, 2025

Publications

linked from the registry
  • Kotani D, Yoshino T, Masuishi T, Sunakawa Y, Takashima A, Yamazaki K, Kawakami H, Nishina T, Komatsu Y, Esaki T, Eng C, Ukrainskyj S, Pallai R, Nanda S, Yang Z, Schelman W, Kania M, Satoh T. Efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer: a FRESCO-2 subgroup analysis of patients enrolled in Japan. Int J Clin Oncol. 2025 Oct;30(10):2043-2052. doi: 10.1007/s10147-025-02852-9. Epub 2025 Sep 1. PubMed 40888992
  • Zhou X, Toms A, Morton D, Wang X, Taylor A, Dasari A, Gupta N, Chien C. Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer. J Clin Pharmacol. 2025 Nov;65(11):1411-1419. doi: 10.1002/jcph.70051. Epub 2025 Jun 8. PubMed 40485075
  • Eng C, Dasari A, Lonardi S, Garcia-Carbonero R, Elez E, Yoshino T, Sobrero A, Yao J, Garcia-Alfonso P, Kocsis J, Gracian AC, Sartore-Bianchi A, Satoh T, Randrian V, Tomasek J, Chong G, Yang Z, Guevara F, Schelman W, Pallai R, Tabernero J. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer: safety analysis of FRESCO-2. Oncologist. 2025 Mar 10;30(3):oyae360. doi: 10.1093/oncolo/oyae360. PubMed 40163688
  • Sobrero A, Dasari A, Aquino J, Lonardi S, Garcia-Carbonero R, Elez E, Yoshino T, Yao J, Garcia-Alfonso P, Kocsis J, Gracian AC, Sartore-Bianchi A, Satoh T, Randrian V, Tomasek J, Chong G, Price T, Yu Z, Geiger A, Chen L, Yang Z, Schelman WR, Kania M, Tabernero J, Eng C. Health-related quality of life associated with fruquintinib in patients with metastatic colorectal cancer: Results from the FRESCO-2 study. Eur J Cancer. 2025 Mar 11;218:115268. doi: 10.1016/j.ejca.2025.115268. Epub 2025 Jan 29. PubMed 39952149
  • Dasari A, Lonardi S, Garcia-Carbonero R, Elez E, Yoshino T, Sobrero A, Yao J, Garcia-Alfonso P, Kocsis J, Cubillo Gracian A, Sartore-Bianchi A, Satoh T, Randrian V, Tomasek J, Chong G, Paulson AS, Masuishi T, Jones J, Csoszi T, Cremolini C, Ghiringhelli F, Shergill A, Hochster HS, Krauss J, Bassam A, Ducreux M, Elme A, Faugeras L, Kasper S, Van Cutsem E, Arnold D, Nanda S, Yang Z, Schelman WR, Kania M, Tabernero J, Eng C; FRESCO-2 Study Investigators. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. 2023 Jul 1;402(10395):41-53. doi: 10.1016/S0140-6736(23)00772-9. Epub 2023 Jun 15. PubMed 37331369
  • Dasari A, Sobrero A, Yao J, Yoshino T, Schelman W, Yang Z, Chien C, Kania M, Tabernero J, Eng C. FRESCO-2: a global Phase III study investigating the efficacy and safety of fruquintinib in metastatic colorectal cancer. Future Oncol. 2021 Aug;17(24):3151-3162. doi: 10.2217/fon-2021-0202. Epub 2021 May 17. PubMed 33993740