Pancreatic cancer and Biliary Tract Cancer
Conditions
Interventions
treatment group:SHR-1701 + Famitinib
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in and sign the informed consent ; 2. Male or female subjects aged between 18 and 75 years; 3. Histologically or cytologically confirmed pancreatic cancer or biliary tract cancer that failed or intolerated standard first-line treatment. There is at least one measurable disease per RECIST 1.1; 4. Life expectancy >= 3 months as judged by the investigator; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; 6. Has adequate organ and bone marrow function; 7. The patients are expected to have good compliance and will be able to follow up according to the requirements of the program.
Exclusion criteria
Exclusion criteria: 1. Prior therapy with an anti-PD1, anti-PD-L1 or anti-CTLA-4; 2. Prior therapy with a TGFß inhibitor; 3. Those who are known to be allergic to the study drug or any of its excipients, or have a severe allergic reaction to other monoclonal antibodies; 4. Prior therapy as follow: a) Major surgery within 28 days before the first dose of study drug (biopsy for diagnostic purposes is allowed); b) Systemic therapy with immunosuppressive agents within 7 days before the first dose of study drug, nasal spray and inhaled corticosteroids or physiological doses of steroid hormones are NOT excluded; c) Received immunomodulatory drugs within 3 weeks prior to the first dose of study drug (eg, thymosin, interferon, interleukinin); d) Vaccination within 28 days before the first dose of study drug, or live-attenuated vaccine is planned during the study or within 60 days after the last dose of study drug; e) Anticancer treatment within 28 days before the first dose of study drug. 5. Other serious physical or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, as well as subjects who the investigator believes are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression free survival;Overall survival;Quality of Life;Safety; | — |
Countries
China
Contacts
Public ContactMeng Zhiqiang
Shanghai Tumor Hospital
Outcome results
None listed