Fruquintinib and Raltitrexed Versus Fruquintinib Monotherapy in Advanced Colorectal Cancer
NCT ID: NCT04582981
Last Updated: 2021-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
136 participants
INTERVENTIONAL
2020-09-28
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Combination treatment of Fruquintinib and Raltitrexed
Fruquintinib and raltitrexed
Fruquintinib 5mg qd plus raltitrexed 2mg/m2, q2w
Arm B
Monotherapy of Fruquintinib
Fruquintinib
Fruquintinib 5mg qd monotherapy
Interventions
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Fruquintinib and raltitrexed
Fruquintinib 5mg qd plus raltitrexed 2mg/m2, q2w
Fruquintinib
Fruquintinib 5mg qd monotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. confirmed by histopathological examination, recurrent/metastatic colorectal adenocarcinoma
3. had received at least two lines standard chemotherapy and failed. These standard regimens must include fluorouracil, oxaliplatin, and irinotecan. Treatment failure was defined as disease progression within 3 months after the last treatment or intolerance of toxicity or side effects during treatment ; Note: A. each line of treatment shall include more than one cycle of chemotherapeutic agents; B. adjuvant/neoadjuvant therapy is allowed in the former treatment. If recurrence or metastasis occurs during adjuvant/neoadjuvant therapy or within 6 months after completion, adjuvant/neoadjuvant therapy is considered a failure of first-line chemotherapy for the advanced disease; C. Prior antitumor therapy regimens using chemotherapy combined with cetuximab or bevacizumab were permitted.
4. with one or more measurable lesions, according to RECIST criteria, version 1.1;
5. Eastern Cooperative Oncology Group (ECOG) performance score(PS) from 0 to 2;
6. Life expectancy no less than 12 weeks;
7. Acceptable hematologic, hepatic, and renal function within 7 days from screening： the blood neutrophil count≥1.5x109 /L; hemoglobin ≥ 9.0 g/dl，the blood platelet count≥80 x109 /L, total bilirubin \< 1.5 x upper normal limit（UNL), alanine aminotransferase（ALT） and aspartate transaminase（AST）\< 2.5 x UNL(\< 5 x UNL for patients with live metastasis), serum creatinine≤1 x UNL，endogenous creatinine clearance rate \>50ml/min
8. Women of reproductive age need to take effective contraceptive measures.
9. Participate in this study voluntarily and sign informed consent. Understand the purpose of this study and the necessary procedures. Good compliance to cooperate with the follow-up.
Exclusion Criteria
2. Abnormal coagulation function or those receiving thrombolytics or anticoagulants
3. Patients with tendency of gastrointestinal hemorrhage, including active peptic ulcer with fecal occult blood ++, hematemesis or melena within 3 months
4. Received other systemic anti-tumor therapy, including cell signal transduction inhibitors, drug therapy, immune therapy within 3 weeks
5. With uncontrolled high blood pressure (systolic blood pressure \> 140 MMHG, diastolic blood pressure \> 90 MMHG)
6. Radiotherapy therapy for target lesions
7. symptomatic cerebral or meningeal metastasis;
8. Uncontrolled pleural or peritoneal effusion
9. Undergoing dialysis
10. Severe or uncontrolled infection
11. With multiple factors that affecting oral administration
12. Former exposed to any VEGFR tyrosine kinase inhibitors (e.g regorafenib, apatinib, anlotinib etc.) for treatment
13. Raltitrexed treatment for more than one cycle in former line therapy
18 Years
ALL
No
Sponsors
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Shanxi Province Cancer Hospital
OTHER
Fudan University
OTHER
Responsible Party
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Weijian Guo
Professor
Principal Investigators
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Weijian Guo
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wei Jian Guo, PHD
Role: primary
References
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Li J, Qin S, Xu RH, Shen L, Xu J, Bai Y, Yang L, Deng Y, Chen ZD, Zhong H, Pan H, Guo W, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Chen D, Li W, Sun S, Yu Z, Cao P, Chen H, Wang J, Wang S, Wang H, Fan S, Hua Y, Su W. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018 Jun 26;319(24):2486-2496. doi: 10.1001/jama.2018.7855.
Pfeiffer P, Yilmaz M, Moller S, Zitnjak D, Krogh M, Petersen LN, Poulsen LO, Winther SB, Thomsen KG, Qvortrup C. TAS-102 with or without bevacizumab in patients with chemorefractory metastatic colorectal cancer: an investigator-initiated, open-label, randomised, phase 2 trial. Lancet Oncol. 2020 Mar;21(3):412-420. doi: 10.1016/S1470-2045(19)30827-7. Epub 2020 Jan 27.
Cunningham D, Zalcberg JR, Rath U, Oliver I, van Cutsem E, Svensson C, Seitz JF, Harper P, Kerr D, Perez-Manga G. Final results of a randomised trial comparing 'Tomudex' (raltitrexed) with 5-fluorouracil plus leucovorin in advanced colorectal cancer. "Tomudex" Colorectal Cancer Study Group. Ann Oncol. 1996 Nov;7(9):961-5. doi: 10.1093/oxfordjournals.annonc.a010800. No abstract available.
Other Identifiers
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FDZL-FRaF
Identifier Type: -
Identifier Source: org_study_id