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NCT03982680
Toripalimab Combined With Gemcitabine/5--fluoropyrimidine for Advanced Cholangiocarcinoma
Phase 2 trial testing Toripalimab in Advanced Cholangiocarcinoma in 30 participants. Status unknown.
30 May 2021
Quick facts
| Lead sponsor | Jiangmen Central Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 13 July 2019 |
| Primary completion | 30 May 2021 |
| Estimated completion | 30 December 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Toripalimab (TORIPALIMAB) — full drug profile →
- Gemcitabine (gemcitabine) — full drug profile →
- 5- fluorine pyrimidine — full drug profile →
Conditions studied
- Advanced Cholangiocarcinoma — all drugs for Advanced Cholangiocarcinoma →
Sponsor
Jiangmen Central Hospital
Who can join
Adults 18 to 70, any sex, with Advanced Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is a phase II clinical trial of single arm. The purpose is to evaluate the safety and efficacy of anti-PD-1 antibody Toripalimab combined with chemotherapy(gemcitabine+5-fluorine pyrimidine) in unresectable advanced cholangiocarcinoma patients.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Biliary Tract Cancer: Current Medical Treatment Strategies.
Oneda E, Abu Hilal M, Zaniboni A. · · 2020 · cited 47× · PMID 32423017 · DOI 10.3390/cancers12051237 -
Immune Therapy for Liver Cancers.
Hilmi M, Vienot A, Rousseau B, Neuzillet C. · · 2019 · cited 37× · PMID 31892230 · DOI 10.3390/cancers12010077 -
Immunotherapy in Advanced Biliary Tract Cancers.
Boilève A, Hilmi M, Smolenschi C, Ducreux M, et al · · 2021 · cited 32× · PMID 33805461 · DOI 10.3390/cancers13071569 -
Application of Immune Checkpoint Inhibitors in the Treatment of Cholangiocarcinoma.
Zeng FL, Chen JF. · · 2021 · cited 24× · PMID 34528830 · DOI 10.1177/15330338211039952 -
Role of Immune Checkpoint Inhibitors in Gastrointestinal Malignancies.
Mazloom A, Ghalehsari N, Gazivoda V, Nimkar N, et al · · 2020 · cited 17× · PMID 32781500 · DOI 10.3390/jcm9082533 -
Systemic treatment options for advanced biliary tract carcinoma.
Xie C, McGrath NA, Monge Bonilla C, Fu J. · · 2020 · cited 17× · PMID 32748173 · DOI 10.1007/s00535-020-01712-9 -
Targeted therapies for extrahepatic cholangiocarcinoma: preclinical and clinical development and prospects for the clinic.
Cadamuro M, Lasagni A, Lamarca A, Fouassier L, et al · · 2021 · cited 6× · PMID 33622120 · DOI 10.1080/13543784.2021.1880564 -
Emerging treatment evolutions and integrated molecular characteristics of biliary tract cancers.
Zhang R, Puzzoni M, Mariani S, Zheng Y, et al · · 2021 · cited 5× · PMID 34534382 · DOI 10.1111/cas.15139
Verify or expand the search:
- PubMed search for NCT03982680
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Toripalimab
Trials testing the same drug.
- NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
- NCT07423078 — Window of Opportunity in Preserving Laryngeal Function Trial · Phase 2 · recruiting
- NCT07480733 — Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting
- NCT07320963 — Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma. · Phase 1, PHASE2 · not yet recruiting
- NCT07469956 — Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancre · Phase 2 · not yet recruiting
Other recruiting trials for Advanced Cholangiocarcinoma
Currently open trials in the same condition.
- NCT06439485 — Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarc · Phase 1, PHASE2 · recruiting
- NCT05823311 — Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma · Phase 3 · recruiting
- NCT05969860 — At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer · Phase 2 · recruiting
- NCT05791448 — AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease · Phase 1 · recruiting
- NCT05532059 — Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma · Phase 2 · recruiting
Other Jiangmen Central Hospital trials
Trials by the same sponsor.
- NCT07482605 — Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion · 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 NCT03982680 (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 Jiangmen Central Hospital
- Last refreshed: 16 July 2019
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/NCT03982680.
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