Last reviewed · How we verify
NCT03125161
Study Comparing HAI Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM
Phase 3 trial testing HAI in Colorectal Adenocarcinoma Metastatic to the Liver in 150 participants. Status unknown.
31 December 2020
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 | 150 |
| Start date | 30 April 2017 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- HAI — full drug profile →
- chemotherapy ± target therapy — full drug profile →
Conditions studied
- Colorectal Adenocarcinoma Metastatic to the Liver — all drugs for Colorectal Adenocarcinoma Metastatic to the Liver →
Sponsor
Fudan University
Who can join
Adults 18 to 75, any sex, with Colorectal Adenocarcinoma Metastatic to the Liver. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To date no prospective trials have been completed that demonstrated whether HAI is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversional resection rates and survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine conversional resection rates and survival for patients with colorectal cancer liver metastasis are treated with HAI plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.
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 NCT03125161
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03125161 (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: 24 April 2017
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/NCT03125161.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing