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NCT04296019
Fruquintinib as a Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer
Phase 2 trial testing Fruquintinib in Colo-rectal Cancer in 110 participants. Status unknown.
1 July 2023
Quick facts
| Lead sponsor | Shanghai Zhongshan Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 1 February 2021 |
| Primary completion | 1 July 2023 |
| Estimated completion | 1 January 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Fruquintinib — full drug profile →
Conditions studied
- Colo-rectal Cancer — all drugs for Colo-rectal Cancer →
Sponsor
Shanghai Zhongshan Hospital
Who can join
Adults 18 to 75, any sex, with Colo-rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study was a randomized, controled, multicenter, phase II clinical study evaluating the efficacy and safety of fruquintinib as a maintenance therapy following first-line treatment for metastatic colorectal cancer. This study will include the patients with confirmed unresectable metastatic left-sided colon cancer with RAS mutation or right-sided colon cancer who achieved stable disease (SD) or partial response (PR) or complete response (CR) via palliative first-line treatment. It's expected to include 110 patients and they will be randomly stratified at 2:1 into fruquintinib group and observation group based on whether bevacizumab is used and the primary tumor site, using the Interactive Network Response System (IWRS). The random No. corresponds to the respective patient. The enrollment time is expected to be 18 months, followed up for 24 months.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Previous Use of Anti-Vascular Endothelial Growth Factor Receptor Agents Decreases Efficacy of Fruquintinib in Metastatic Colorectal Cancer Refractory to Standard Therapies.
Wang L, Cao H, Jiang C, He W, et al · · 2020 · cited 4× · PMID 33282739 · DOI 10.3389/fonc.2020.587692 -
Clinical Progress of Fruquintinib in Colorectal Cancer: An Overview.
Xie Y, Tang S, Qin Z, Yang C. · · 2025 · cited 3× · PMID 40006092 · DOI 10.3390/ph18020280 -
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:
- PubMed search for NCT04296019
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fruquintinib
Trials testing the same drug.
- NCT07510932 — Fruquintinib In Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies in South Korea Patients · Phase 2 · not yet recruiting
- NCT07502014 — A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruqui · Phase 2 · not yet recruiting
- NCT07124858 — Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metast · NA · not yet recruiting
- NCT07446465 — FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectab · Phase 4 · not yet recruiting
- NCT07235293 — A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorecta · Phase 2 · recruiting
Other recruiting trials for Colo-rectal Cancer
Currently open trials in the same condition.
- NCT06645015 — The AIDPRO-CRC Trial · NA · recruiting
- NCT07145255 — Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07085169 — Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC · Phase 2 · recruiting
- NCT06880055 — Shield Post-Approval Study Protocol · recruiting
- NCT06905925 — The Effect of the Training Program Given to Permanent Colostomy Patients on Self-efficacy · NA · recruiting
Other Shanghai Zhongshan Hospital trials
Trials by the same sponsor.
- NCT07353476 — Radiotherapy Plus Anti-PD-1 Versus Anti-PD-1 Alone in ypTanyN⁺M0 NSCLC · Phase 2 · not yet recruiting
- NCT07508956 — Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric · Phase 3 · not yet recruiting
- NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance · Phase 2 · not yet recruiting
- NCT07531368 — BBAP With CS Mapping Guidance · NA · not yet recruiting
- NCT07501104 — Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04296019 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Zhongshan Hospital
- Last refreshed: 3 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04296019.
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