NCT04027764

Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer

Status unknown Phase 2 Last updated 22 July 2019

What this trial tests

Phase 2 trial testing Toripalimab Combined With S1 and Albumin Paclitaxel in Advanced Biliary Tract Cancer in 30 participants. Status unknown.

Timeline

1 May 2019

Primary endpoint
1 May 2020

1 May 2021

Quick facts

Lead sponsor	Dai, Guanghai
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 May 2019
Primary completion	1 May 2020
Estimated completion	1 May 2021
Sites	1 location across China

Drugs / interventions tested

• Toripalimab Combined With S1 and Albumin Paclitaxel — full drug profile →

Conditions studied

• Advanced Biliary Tract Cancer — all drugs for Advanced Biliary Tract Cancer →

Sponsor

Dai, Guanghai — full company profile →

Who can join

18 and older, any sex, with Advanced Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigator's study is a single armed phrase II trial ,aiming to improve the effecacy of treatment for advanced billiary tract cancer by means of Toripalimab combining with S1 and Albumin Paclitaxel as first line in patients with advanced Biliary Tract Cancer. treatment continually until disease progression or intolerable toxicity or Patients withdrawal of consent.and target sample is 30+ patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PD-L1, TMB, MSI, and Other Predictors of Response to Immune Checkpoint Inhibitors in Biliary Tract Cancer.
   Rizzo A, Ricci AD, Brandi G. · · 2021 · cited 207× · PMID 33535621 · DOI 10.3390/cancers13030558
2. Biliary Tract Cancer: Current Medical Treatment Strategies.
   Oneda E, Abu Hilal M, Zaniboni A. · · 2020 · cited 47× · PMID 32423017 · DOI 10.3390/cancers12051237
3. Current and novel therapeutic opportunities for systemic therapy in biliary cancer.
   Marin JJG, Prete MG, Lamarca A, Tavolari S, et al · · 2020 · cited 45× · PMID 32694694 · DOI 10.1038/s41416-020-0987-3
4. Immune Therapy for Liver Cancers.
   Hilmi M, Vienot A, Rousseau B, Neuzillet C. · · 2019 · cited 37× · PMID 31892230 · DOI 10.3390/cancers12010077
5. 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
6. Changing Landscape of Systemic Therapy in Biliary Tract Cancer.
   Woods E, Le D, Jakka BK, Manne A. · · 2022 · cited 31× · PMID 35565266 · DOI 10.3390/cancers14092137
7. Immunotherapy for Biliary Tract Cancer in the Era of Precision Medicine: Current Knowledge and Future Perspectives.
   Ciardiello D, Maiorano BA, Parente P, Rodriquenz MG, et al · · 2022 · cited 19× · PMID 35055006 · DOI 10.3390/ijms23020820
8. 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