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NCT03545711
Safety and Efficacy of Anlotinib in Combination With Irinotecan in Patients With Pretreated Advanced Colorectal Cancer
Phase 1, PHASE2 trial testing Anlotinib Hydrochloride with Irinotecan in Colo-rectal Cancer in 42 participants. Status unknown.
24 November 2019
Quick facts
| Lead sponsor | Chinese Academy of Medical Sciences |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 26 May 2018 |
| Primary completion | 24 November 2019 |
| Estimated completion | 24 November 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Anlotinib Hydrochloride with Irinotecan — full drug profile →
Conditions studied
- Colo-rectal Cancer — all drugs for Colo-rectal Cancer →
Sponsor
Chinese Academy of Medical Sciences — full company profile →
Who can join
Adults 18 to 70, any sex, with Colo-rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with pretreated advanced colorectal cancer are recruited to the phase I portion of this prospective non-randomised study in an escalated dose cohort. The primary endpoint of the dose-escalation phase is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of anlotinib when given in combination with irinotecan. The phase II (dose-expansion) portion is designed to characterize the safety and potential efficacy of the combination therapy in pretreated advanced colorectal cancer patients.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Anlotinib as a molecular targeted therapy for tumors.
Gao Y, Liu P, Shi R. · · 2020 · cited 108× · PMID 32724339 · DOI 10.3892/ol.2020.11685
Verify or expand the search:
- PubMed search for NCT03545711
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Chinese Academy of Medical Sciences trials
Trials by the same sponsor.
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- NCT05499715 — A Phase I Clinical Study to Evaluate the Safety, the Tolerability, the Pharmacokinetic Characteristics and the Efficacy · Phase 1 · unknown
- NCT05484024 — Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer · Phase 2, PHASE3 · not yet recruiting
- NCT05543070 — Low-dose Radiotherapy in iNHL · Phase 2 · unknown
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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 NCT03545711 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Chinese Academy of Medical Sciences
- Last refreshed: 6 August 2018
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/NCT03545711.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing