NCT03486678

SHR-1210 in Combination With GEMOX in Patients With Advanced BTC

Completed Phase 2 Last updated 28 October 2021

What this trial tests

Phase 2 trial testing SHR-1210+GEMOX in Biliary Tract Cancer in 38 participants. Completed in 30 November 2020.

Timeline

10 February 2018

Primary endpoint
1 August 2020

30 November 2020

Quick facts

Lead sponsor	The First Affiliated Hospital with Nanjing Medical University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	10 February 2018
Primary completion	1 August 2020
Estimated completion	30 November 2020
Sites	1 location across China

Drugs / interventions tested

• SHR-1210+GEMOX — full drug profile →

Conditions studied

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

Adults 18 to 75, any sex, with Biliary Tract Cancer or Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-arm, open-label and exploratory clinical study of PD-1 monoclonal antibody SHR-1210 combined with GEMOX regimen (gemcitabine combined oxaliplatin) in the treatment of advanced biliary malignancies.

In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined with GEMOX in the treatment of patients with advanced biliary malignant tumor (BTC),subjects with pathological confirmed biliary cancer, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma will be enrolled.

28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy will be used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond 6 cycles chemotherapy until disease progression or un-tolerable toxicity.

Publications & conference data

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

1. Camrelizumab plus gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer: a single-arm, open-label, phase II trial.
   Chen X, Wu X, Wu H, Gu Y, et al · · 2020 · cited 137× · PMID 33172881 · DOI 10.1136/jitc-2020-001240
2. Immunobiology of cholangiocarcinoma.
   Loeuillard E, Conboy CB, Gores GJ, Ilyas SI. · · 2019 · cited 88× · PMID 32039381 · DOI 10.1016/j.jhepr.2019.06.003
3. Genomic alterations in biliary tract cancer predict prognosis and immunotherapy outcomes.
   Chen X, Wang D, Liu J, Qiu J, et al · · 2021 · cited 54× · PMID 34795005 · DOI 10.1136/jitc-2021-003214
4. 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
5. Immune Therapy for Liver Cancers.
   Hilmi M, Vienot A, Rousseau B, Neuzillet C. · · 2019 · cited 37× · PMID 31892230 · DOI 10.3390/cancers12010077
6. Tumor Microenvironment and its Implications for Antitumor Immunity in Cholangiocarcinoma: Future Perspectives for Novel Therapies.
   Cao H, Huang T, Dai M, Kong X, et al · · 2022 · cited 32× · PMID 36147461 · DOI 10.7150/ijbs.73949
7. 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
8. Evolving Role of Immunotherapy in Advanced Biliary Tract Cancers.
   Kang S, El-Rayes BF, Akce M. · · 2022 · cited 25× · PMID 35406520 · DOI 10.3390/cancers14071748