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NCT05771181
Phase II Clinical Study of Vitamin E Combined With Fruquintinib and Tislelizumab in Patients With Microsatellite Stabilized Metastatic Colorectal Cancer Who Failed Standard Therapy
Phase 2 trial testing Vitamin E in Colorectal Cancer in 25 participants. Currently enrolling.
1 December 2025
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 1 March 2023 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 February 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Vitamin E (VITAMIN E) — full drug profile →
- Fruquintinib — full drug profile →
- Tislelizumab (TISLELIZUMAB) — full drug profile →
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Microsatellite Stable Colorectal Carcinoma — all drugs for Microsatellite Stable Colorectal Carcinoma →
Sponsor
Fudan University
Who can join
18 and older, any sex, with Colorectal Cancer or Microsatellite Stable Colorectal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
objective response rate (ORR)
Time frame: 2 year
The proportion of participants whose best outcome is complete remission or partial remission
Sponsor's own description
The goal of this clinical trial is to learn about efficacy of Vitamin E in combination with Fuquinitinib and Tirelizumab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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
Verify or expand the search:
- PubMed search for NCT05771181
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Colorectal Cancer
Currently open trials in the same condition.
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Other Fudan University trials
Trials by the same sponsor.
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- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · 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 NCT05771181 (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 Fudan University
- Last refreshed: 9 June 2025
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/NCT05771181.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing