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NCT05487443
The Efficacy of Chemotherapy Combined With Immunocheckpoint Inhibitors in Advanced Biliary Malignancies
Phase 2, PHASE3 trial testing Gemcitabine-based chemotherapy regimen combined with immunocheckpoint inhibitors in Gemcitabine in 50 participants. Status unknown.
30 September 2023
Quick facts
| Lead sponsor | First People's Hospital of Hangzhou |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 August 2022 |
| Primary completion | 30 September 2023 |
| Estimated completion | 30 August 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Gemcitabine-based chemotherapy regimen combined with immunocheckpoint inhibitors — full drug profile →
Conditions studied
- Gemcitabine — all drugs for Gemcitabine →
- Biliary Tract Cancer — all drugs for Biliary Tract Cancer →
- Immune Checkpoint Inhibitors — all drugs for Immune Checkpoint Inhibitors →
Sponsor
First People's Hospital of Hangzhou
Who can join
Adults 18 to 80, any sex, with Gemcitabine or Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To the patient of terminal biliary malignancy tumor, how should the patient's treatment plan choose ? To address this problem, this study intends to analyze systemic venous gemcitabine-based chemotherapy regimen combined with immune checkpoint inhibitors in patients with advanced BTC, to evaluate the long-term efficacy and toxicity of patients, and to search for predictable biomarkers. In order to clarify the advantages and disadvantages of intravenous chemotherapy combined with immunotherapy for patients with advanced biliary malignancy, provide certain basis for clinical work, and then select the most suitable treatment plan for patients according to the different characteristics of individual patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05487443
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Related trials
Other recruiting trials for Gemcitabine
Currently open trials in the same condition.
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- NCT06156514 — Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer · Phase 3 · recruiting
Other First People's Hospital of Hangzhou 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 NCT05487443 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First People's Hospital of Hangzhou
- Last refreshed: 4 August 2022
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/NCT05487443.
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