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Gemcitabine

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Immunoglobulins

Patients will be given treatment as below once recruited: PD-1 antibody Toripalimab（240mg, iv, q3w），combined with GS regimen(gemcitabine 1000mg／m2 ，d1,d8 + S1 40-60mg bid\*14d，Q21d).

The treatment will be continued until emerging of disease progression or intolerable adverse effects (The upper time limit for treatment is 2 years).

GS+Toripalimab

Tianshu Liu, Doctor

1. Target population: patients with advanced biliary tract cancer (including gallbladder carcinoma, intrahepatic and extrahepatic cholangiocarcinoma) .
2. Primary objective: progression free survival (PFS)/ overall survival (OS) of first-line chemotherapy plus PD-1 antibody (Toripalimab) in patients with advanced biliary tract cancer.

Secondary objectives:

1. objective response rate (ORR) of first-line chemotherapy plus PD-1 antibody (Toripalimab)
2. safety of first-line chemotherapy plus PD-1 antibody (Toripalimab)

3.Trial design: This is a monocenter, single arm, phase II study to evaluate the efficacy and safety of first-line chemotherapy plus PD-1 antibody (Toripalimab) in patients with advanced advanced biliary tract cancer.

4.Treatment plan: Patients will be given treatment as below once recruited: PD-1 antibody Toripalimab（240mg, iv, q3w），combined with GS regimen(gemcitabine 1000mg／m2 ，d1,d8 + S1 40-60mg bid\*14d，Q21d).

The treatment will be continued until emerging of disease progression or intolerable adverse effects (The upper time limit for treatment is 2 years).

5.Number of subjects: 40 patients. Number of centers: 1 sites ( Fudan University Affiliated Zhongshan Hospital).

Backgrounds:

Toripalimab (JS-001) is a PD-1 antibody developed by Shanghai Jun Shi Biomedical technology Co. Ltd. Nowadays, eighteen clinical trials of this drug have been conducted in patients with different types of advanced malignant tumor. Until now, Toripalimab has exhibited favorable safety in recruited patients. Incidence rate of SAE is 14.7%. JS001-Ib-CRP-1.0 is a phase Ib/II basket trial, aiming at evaluating safety and efficacy of JS001 in treating advanced gastric adenocarcinoma, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and head and neck squamous cell carcinoma.The interim analyses results of 161 patients show that the ORR is 22.4%.

Now, the standard chemotherapies regimen for advanced biliary tract cancer include gemcitabine, platinum and fluorouracil; Considering the synergistic effect of chemotherapy and immune therapy, the investigators choose GS regimen (gemcitabine+S1) to combine Toripalimab.

the investigators will shut down the study in advance, if unpredicted SAE or low efficacy occur.

Patients with abnormal autoimmune status, unfavorable body function, factors impeding drug taking, absorption and metabolism will be excluded. Study participants with disease progression or severe/ intolerant toxicity during treatment will withdraw the study.

Hyper-progressive disease is defined as 1) progression 2) more than doubled growth rate 3) tumor volume increase \>50% in 2 months after initialing the treatment.

A Study of the Efficacy and Safety of Chemotherapy Combined With Toripalimab in Advanced Biliary Tract Cancer

A Single-arm, Single-center, Prospective Clinical Study of the Efficacy and Safety of Chemotherapy Combined With Toripalimab in the Treatment of Advanced Biliary Tract Cancer

PFS is defined as time interval from recruitment to tumor progression or censoring. Tumor progression is defined as below: 1) relapse of primary lesion 2) emerging of new lesion 3) distant metastasis 4) death of any reason 5)tumor progression according to RESIST 1.1 on CT/MRI.

OS is defined as time interval from recruitment to all-caused death or censoring.

rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1. ORR was evaluated by chest, abdominal \& pelvic CT/MRI. Evaluation will be conducted every 6 weeks during treatment, and every 0.5 year after all treatments.

Adverse events (AE) of chemotherapy will be graded and documented according to NCI-CTC AE v4.03 from the beginning of treatment to 1 months after the last date of treatment. Documentary will include severity, lasting period and occurrence time. Main AEs include vomiting, diarrhea, anemia, leukopenia, thrombocytopenia, hand-foot syndrome, immune related adverse events (including interstitial lung disease, AST/ALT elevations, hypothyroidism and hyperthyroidism,etc) and hyper-progressive tumor.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of the Efficacy and Safety of Chemotherapy Combined With Toripalimab in Advanced Biliary Tract Cancer	NCT03796429	Biliary Tract C...	GS+Toripalimab	18 Years - 75 Years	Shanghai Zhongshan Hospital
A Study of the Efficacy and Safety of Chemotherapy Combined With Toripalimab in Advanced Biliary Tract Cancer	NCT03796429	Biliary Tract C...	GS+Toripalimab	18 Years - 75 Years	Shanghai Zhongshan Hospital
A Study of the Efficacy and Safety of Chemotherapy Combined With Toripalimab in Advanced Biliary Tract Cancer	NCT03796429	Biliary Tract C...	GS+Toripalimab	18 Years - 75 Years	Shanghai Zhongshan Hospital

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