Last reviewed · How we verify
NCT04525326
Conversion Therapy of RAS/BRAF Wild-Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases
Phase 3 trial testing Cetuximab in Colorectal Cancer in 584 participants. Status unknown.
1 October 2022
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 584 |
| Start date | 1 October 2020 |
| Primary completion | 1 October 2022 |
| Estimated completion | 1 November 2022 |
Drugs / interventions tested
- Cetuximab (cetuximab) — full drug profile →
- Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
- mFOLFOX/FOLFIRI ( Standard Chemotherapy) — full drug profile →
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Liver Metastases — all drugs for Liver Metastases →
Sponsor
Fudan University
Who can join
Adults 18 to 80, any sex, with Colorectal Cancer or Liver Metastases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The prognosis of patients with metastatic right-sided colon cancer is worse than that of patients with metastatic left-sided cancer. Different guidelines have different recommendations on specific conversion therapy for colorectal liver metastases. The United States NCCN guidelines do not recommend standard chemotherapy combined with anti EGFR monoclonal antibody for patients with right colon cancer. The European ESMO guidelines recommend that patients with Ras / BRAF wild-type right-sided colon cancer should first consider three drugs ± bevacizumab, but considering the objective response rate results, standard chemotherapy + anti EGFR monoclonal antibody is still one of the choices. China CSCO guidelines recommend standard chemotherapy ± bevacizumab, and also recommend standard chemotherapy + cetuximab for patients with right-sided colon cancer. Therefore, the targeted therapy for RAS / BRAF wild-type metastatic right colon cancer is still controversial. Therefore, we are ready to carry out the clinical trial of cetuximab and bevacizumab in conversion therapy for RAS / BRAF wild-type metastatic right colon cancer. The conversion resection rate is the primary point, and the objective response rate, perioperative safety and long-term survival are the secondary points.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Liver Immune Microenvironment and Metastasis from Colorectal Cancer-Pathogenesis and Therapeutic Perspectives.
Zeng X, Ward SE, Zhou J, Cheng ASL. · · 2021 · cited 51× · PMID 34067719 · DOI 10.3390/cancers13102418
Verify or expand the search:
- PubMed search for NCT04525326
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Fudan University trials
Trials by the same sponsor.
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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 NCT04525326 (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: 25 August 2020
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/NCT04525326.
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