A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer
NCT ID: NCT04322539
Last Updated: 2025-04-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
691 participants
INTERVENTIONAL
2020-08-12
2024-04-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Fruquintinib in Patients With Metastatic Colorectal Cancer
NCT02196688
A Phase III Trial Evaluating Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients （FRESCO)
NCT02314819
Fruquintinib as a Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer
NCT04296019
A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers
NCT03251378
Fruquintinib in Patients With Metastatic Colorectal Cancer
NCT06787105
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Metastatic colorectal cancer cannot be cured by surgery. Therefore, treatment principals are primarily aimed at controlling disease progression and prolonging survival. Standard first- and second-line therapy includes cytotoxic drugs such as 5-fluorouracil, oxaliplatin, and irinotecan; anti-VEGF therapy; and, if RAS wild type, anti-EGFR therapy. After the first two lines of chemotherapy, standard third-line treatment is either TAS-102 or regorafenib. There are currently no effective treatments for patients who have progressed on standard, approved therapies, and treatment options include reuse of prior therapies, clinical trials or BSC. Consequently, there is an unmet medical need for additional safe and effective treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fruquintinib Plus Best Supportive Care (BSC) Group
Participants will be orally administered Fruquintinib 5 mg in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break (with each cycle length of 28 days).
Fruquintinib
Oral VEGFR inhibitor
Placebo Plus BSC Group
Participants will be orally administered Placebo 5 mg in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break (with each cycle length of 28 days).
Placebo
Placebo capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fruquintinib
Oral VEGFR inhibitor
Placebo
Placebo capsule
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥18 years;
* Histologically and/or cytologically documented metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability microsatellite instability (MSI)/mismatch repair (MMR) status for each patient must be documented, according to country level guidelines;
* Participants must have progressed on or been intolerant to treatment with either trifluridine/tipiracil (TAS-102) or regorafenib. Participants are considered intolerant to TAS-102 or regorafenib if they have received at least 1 dose of either agents and were discontinued from therapy for reasons other than disease progression. Participants who have been treated with both TAS-102 and regorafenib are permitted. Participants must also have been previously treated with standard approved therapies: fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy;
* Participants with microsatellite-high (MSI-H) or mismatch repair deficient (dMMR) tumors must have been treated with immune checkpoint inhibitors if approved and available in the participant's country unless the patient is ineligible for treatment with a checkpoint inhibitor;
* Participants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxaliplatin in the metastatic setting. Participants who developed metastatic disease more than 6 months after completion of oxaliplatin-containing adjuvant treatment must be treated with oxaliplatin-based therapy in the metastatic setting to be eligible;
* Body weight ≥40kg;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
* Have measurable disease according to RECIST Version 1.1, assessed locally. Tumors that were treated with radiotherapy are not measurable per RECIST Version 1.1, unless there has been documented progression of those lesions;
* Expected survival \>12 weeks.
* For female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use a highly effective form(s) of contraception, that results in a low failure rate (\<1% per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire study period, and for 90 days after taking the last dose of study drug. Such methods include: oral hormonal contraception (combined estrogen/ progestogen, or progestogen-only) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Highly effective contraception should always be combined with an additional barrier method (eg, diaphragm, with spermicide). The same criteria are applicable to male participants involved in this clinical trial if they have a partner of childbirth potential, and male participants must always use a condom.
* Participants with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available in the participant's home country unless the patient is ineligible for treatment with a BRAF inhibitor.
Exclusion Criteria
* Serum total bilirubin \>1.5 × the upper limit of normal (ULN). Participants with Gilbert syndrome, bilirubin \<2 X ULN, and normal AST/ALT are eligible;
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 × ULN in participants without hepatic metastases; ALT or AST \>5 × ULN in participants with hepatic metastases;
* Serum creatinine \>1.5 × ULN or creatinine clearance \<60 mL/min. Creatinine clearance can either be measured in a 24-hour urine collection or estimated by the Cockroft-Gault equation.
* Urine dipstick protein ≥2+ or 24-hour urine protein ≥1.0 g/24-h. Participants with greater than 2+ proteinuria by dipstick must undergo a 24-hour urine collection to assess urine protein level;
* Uncontrolled hypertension, defined as: systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg despite optimal medical management. Participants were required to have blood pressure values below both limits. Repeated assessments were permitted;
* International Normalized Ratio (INR) \>1.5 x ULN or activated partial thromboplastin time (aPTT) \>1.5 × ULN, unless the patient is currently receiving or intended to receive anticoagulants for prophylactic purposes;
* History of, or active gastric/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of perforation or fistulas; or any other condition that could, in the investigator's judgment, result in gastrointestinal hemorrhage or perforation; within the 6 months prior to screening;
* History or presence of hemorrhage from any other site (eg, hemoptysis or hematemesis) within 2 months prior to screening;
* History of a thromboembolic event, including deep vein thrombosis (DVT), pulmonary embolism (PE), or arterial embolism within 6 months prior to screening.
* Stroke and/or transient ischemic attack within 12 months prior to screening;
* Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery within 6 months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment, or left ventricular ejection fraction (LVEF) \<50% by echocardiogram;
* Mean corrected QT interval using the Fridericia method (QTcF) \>480 msec or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in a first-degree relative.
* Concomitant medications with a known risk of causing QT prolongation and/or Torsades de Pointes.
* Systemic anti-neoplastic therapies (except for those described in Exclusion 18) or any investigational therapy within 4 weeks prior to the first dose of study drug, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy;
* Systemic small molecule targeted therapies (eg, tyrosine kinase inhibitors) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug;
* Palliative radiotherapy for bone metastasis/lesion within 2 weeks prior to the initiation of study drug;
* Brachytherapy (i.e., implantation of radioactive seeds) within 60 days prior to the first dose of study drug.
* Use of strong inducers or inhibitors of CYP3A4 within 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug;
* Surgery or invasive procedure (i.e., a procedure that includes a biopsy; central venous catheter placement is allowed) within 60 days prior to the first dose of study drug or unhealed surgical incision;
* Any unresolved toxicities from a previous antitumor treatment greater than CTCAE v5.0 Grade 1 (except for alopecia or neurotoxicity grade≤2);
* Known human immunodeficiency virus (HIV) infection;
* Known history of active viral hepatitis. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
* Clinically uncontrolled active infection requiring IV antibiotics;
* Tumor invasion of a large vascular structure, eg, pulmonary artery, superior or inferior vena cava;
* Women who are pregnant or lactating;
* Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease for 14 days or longer; participants requiring steroids within 4 weeks prior to start of study treatment are excluded;
* Other malignancy, except for non-melanoma skin cancer, in situ cervical ca or bladder ca (Tis and T1) that have been adequately treated during the 5 years prior to screening;
* Inability to take medication orally, dysphagia or an active gastric ulcer resulting from previous surgery (eg, gastric bypass) or a severe gastrointestinal disease, or any other condition that investigators believe may affect absorption of the investigational product;
* Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition (e.g., current alcohol or drug abuse) that investigators suspect may prohibit use of the investigational product, affect interpretation of study results, or put the patient at undue risk of harm based on the investigator's assessment;
* Known hypersensitivity to fruquintinib (or placebo) or any of its inactive ingredients including the azo dyes Tartrazine - FD\&C Yellow 5 and Sunset yellow FCF - FD\&C Yellow 6;
* Participants who have received prior fruquintinib;
* Live vaccine \<28days before the first dose of study drug(s). Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hutchison Medipharma Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
William Schelman, MD, PhD
Role: STUDY_DIRECTOR
HUTCHMED International Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic Arizona
Phoenix, Arizona, United States
Arizona Oncology Associates, PC-HOPE
Tucson, Arizona, United States
California Research Institute (CRI)
Los Angeles, California, United States
City of Hope Comprehensive Cancer Center
Los Angeles, California, United States
Rocky Mountain Cancer Center
Aurora, Colorado, United States
The George Washington University Medical Center
Washington D.C., District of Columbia, United States
Sarah Cannon Research Institute-S-Ft. Myers (FCS South)
Fort Myers, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, United States
Sarah Cannon Research Institute-N-St Pete (FCS North)
St. Petersburg, Florida, United States
Sarah Cannon Research Institute-Pan-Tallahassee (FCS Panhandle)
Tallahassee, Florida, United States
Sarah Cannon Research-E-WPB (Florida Cancer Specialists-FCS East)
West Palm Beach, Florida, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Affiliated Oncologists
Chicago Ridge, Illinois, United States
XCancer / Central Care Cancer Center
Garden City, Kansas, United States
University of Louisville - James Brown Cancer Center
Louisville, Kentucky, United States
Norton Cancer Institute Audubon
Louisville, Kentucky, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
XCancer / Pontchartrain Cancer Center
Hammond, Louisiana, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Minnesota Oncology
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Center for Pharmaceutical Research
Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
XCancer / New Mexico Oncology & Hematology Consultants
Albuquerque, New Mexico, United States
Charleston Oncology
Charleston, South Carolina, United States
Sarah Cannon Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Texas Oncology - Austin
Austin, Texas, United States
Texas Oncology Baylor Sammons
Dallas, Texas, United States
Texas Oncology-El Paso
El Paso, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology-McAllen
McAllen, Texas, United States
Texas Oncology-San Antonio
San Antonio, Texas, United States
Texas Oncology-Tyler
Tyler, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
Medical College of Wisconsin/ Froedtert Hospital
Milwaukee, Wisconsin, United States
Integrated Clinical Oncology Network Pty Ltd (Icon)
Brisbane, Queensland, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Western Health
Melbourne, Victoria, Australia
Austin Hopistal Medical Oncology Unit
Melbourne, Victoria, Australia
Monash Health
Melbourne, Victoria, Australia
Ordensklinikum Linz Barmherzige Schwestern
Linz, AUT, Austria
Schwerpunktkrankenhaus Feldkirch
Rankweil, AUT, Austria
Klinikum Steyr
Steyr, AUT, Austria
Wiener Gesundheitsverbund - Klinik Ottakring
Vienna, AUT, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, AUT, Austria
Landesklinikum Wiener Neustadt
Wiener Neustadt, AUT, Austria
Onze-Lieve-Vrouwziekenhuis OLV - Campus Aalst
Aalst, BEL, Belgium
UCL St-Luc
Brussels, BEL, Belgium
Grand Hopital de Charleroi
Charleroi, BEL, Belgium
UZ Antwerpen
Edegem, BEL, Belgium
Centres Hospitaliers Jolimont
Haine-Saint-Paul, BEL, Belgium
UZ Leuven
Leuven, BEL, Belgium
AZ Delta Roeselare
Roeselare, BEL, Belgium
AZ Turnhout
Turnhout, BEL, Belgium
CHU Mont-Godinne
Yvoir, BEL, Belgium
Clinique CHC MontLegia
Liège, Wallonia, Belgium
CHU de Lige - Domaine Universitaire du Sart Tilman
Liège, Wallonia, Belgium
Masaryk Memorial Cancer Institute, Hematoonkologie
Brno, Moravia, Czechia
Fakultni nemocnice Olomouc, Onkologicka klinika
Olomouc, Moravia, Czechia
Vseobecna Fakultni Nemocnice VFN, Onkologicka Klinika
Prague, , Czechia
East Tallinn Central Hospital Centre of Oncology
Tallinn, Harju, Estonia
Sihtasutus Pohja-Eesti Regionaalhaigla (PERH) (North Estonia Medical Centre)
Tallinn, Harju, Estonia
Tartu University Hospital Clinic of Haematology and Oncology
Tartu, , Estonia
CHU Besancon
Besançon, Franche-Comte, France
Institut Bergonie
Bordeaux, FRA, France
Unicancer
Caen, FRA, France
Centre Georges-Francois Leclerc
Dijon, FRA, France
ICM-Val d'Aurelle
Montpellier, FRA, France
Saint-Louis Hospital
Paris, FRA, France
Hopital St Antoine
Paris, FRA, France
Hopital Pitie Salptriere
Paris, FRA, France
CHU Poitiers
Poitiers, FRA, France
Centre hospitalier Annecy Genevois
Pringy, FRA, France
Centre Hospitalier Universitaire CHU de Rennes - Hopital de Pontchaillou
Rennes, FRA, France
Institut de cancerologie Strasbourg-Europe
Strasbourg, FRA, France
Institut Gustave Roussy
Villejuif, Paris, France
Universitaetsklinikum Erlangen
Erlangen, Bavaria, Germany
HELIOS Klinikum Berlin-Buch Saarow
Berlin, DEU, Germany
Charite - Universitaetsmedizin Berlin
Berlin, DEU, Germany
Universitaetsklinik Dresden
Dresden, DEU, Germany
University Hospital Essen
Essen, DEU, Germany
Institut fr Klinisch Onkologische ForschungKrankenhaus Nordwest GmbH
Frankfurt am Main, DEU, Germany
Haematologisch-Onkologische Praxis Hamburg Eppendorf
Hamburg, DEU, Germany
Asklepios Tumorzentrum Hamburg AK Altona
Hamburg, DEU, Germany
Universitaeres Krebszentrum Leipzig
Leipzig, DEU, Germany
RKH Kliniken
Ludwigsburg, DEU, Germany
Universitaetsmedizin Mannheim- III. Medizinische Klinik
Mannheim, DEU, Germany
Klinikum Neuperlach
München, DEU, Germany
Zentrum für Hämatologie und Onkologie MVZ GmbH
Porta Westfalica, DEU, Germany
Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet, Szent Laszlo Korhaz
Budapest, HUN, Hungary
National Institute of Oncology
Budapest, HUN, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, HUN, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, HUN, Hungary
Bacs- Kiskun Megyei Korhaz
Kecskemét, HUN, Hungary
Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, HUN, Hungary
Hetenyi G Korhaz, Onkologiai Kozpont
Szolnok, HUN, Hungary
Szent Borbala Korhaz
Tatabánya, HUN, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz, Klinikai Onkologiai Osztaly
Kaposvár, Somogy County, Hungary
Zala Megyei Szent Rafael Korhaz, Onkologiai Osztaly, F epulet 3. em.
Zalaegerszeg, Zala County, Hungary
Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Megyei Onkologiai Kozpont
Gyula, , Hungary
Fondazione Poliambulanza Hospital
Brescia, ITA, Italy
Policlinico San Martino di Genova
Genova, ITA, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, ITA, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, ITA, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, ITA, Italy
Istituto Oncologico Veneto Irccs
Padua, ITA, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, ITA, Italy
Azienda USL-IRCCS di Reggio Emilia
Reggio Emilia, ITA, Italy
AO Card G Panico
Tricase, ITA, Italy
Ospedale San Bortolo Azienda ULSS8 Berica - Distretto Est
Vicenza, ITA, Italy
Istituto Clinico Humanitas
Rozzano MI, Lombardy, Italy
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
St. Marianna University School of Medicine Hospital
Kawasaki-shi, Kanagawa, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
Osaka University Hospital
Suita-shi, Osaka, Japan
Shizuoka Cancer Center
Shizuoka, Sunto-gun, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
M Sklodowska Curie Memorial Cancer Center, Klinika Gastroenterologii Onkologicznej
Warsaw, Masovia, Poland
Bialostockie Centrum Onkologii im. Marii Skodowskiej-Curie
Bialystok, Podlaskie Voivodeship, Poland
Hospital Universitari Vall dHebron
Barcelona, ESP, Spain
Hospital Universitario Reina Sofa
Córdoba, ESP, Spain
Hospital General Universitario de Elche
Elche, ESP, Spain
Hospital Universitario Ramón y Cajal
Madrid, ESP, Spain
Hospital Clinico San Carlos
Madrid, ESP, Spain
Hospital Universitario 12 de Octubre
Madrid, ESP, Spain
Hospital Universitario La Paz
Madrid, ESP, Spain
Hospital Universitario HM Sanchinarro
Madrid, ESP, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, ESP, Spain
Hospital Regional Universitario Carlos Haya
Málaga, ESP, Spain
Hospital Universitario Central de Asturias
Oviedo, ESP, Spain
Hospital Universitario Marques de Valdecilla
Santander, ESP, Spain
Hospital ClÃ-nico Universitario de Santiago-CHUS
Santiago de Compostela, ESP, Spain
Hospital General Universitario Gregorio Maranon HGUGM
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Aberdeen Royal Infirmary
Aberdeen, GBR, United Kingdom
The Royal Marsden Hospital
London, GBR, United Kingdom
Sarah Cannon Research Institute UK
London, Middlesex, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-013-GLOB1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.