Advanced Biliary Tract Cancer
Conditions
Brief summary
This research study is designed to establish whether the combination of IBI310 & Sintilimab has efficacy in patients with advanced BTC
Interventions
DRUGIBI310
2mg/kg IV,3 weeks later, 1mg/kg IV Q6W
DRUGsintilimab
200mg IV Q3W
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol. 2. Aged ≥18 years. 3. Patients with unresectable or relapsed or metastatic advanced Biliary tract cancer,and diagnosed by histology/cytology (except carcinoma of ampulla). 4. Had progressed after receiving at least first-line systemic treatment (if a patient has progressed within 6 months after receiving systemic treatment during adjuvant chemotherapy or concurrent radiochemotherapy, she will be deemed to have received first-line treatment). 5. Patients who have never received any anti-PD-1, anti-PD-L1/L2 antibody, anti-CTLA-4 antibody, or other immunotherapy. 6. The subject must have at least one measurable lesion as the target lesion (according to RECIST V1.1). A measurable lesion in the radiation field from previous radiotherapy or local treatment, can also be chosen as the target lesion if confirmed progression.
Exclusion criteria
1. Diagnosis of other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, radically resected carcinoma in situ and/or thyroid papillary carcinoma. 2. Patients who have previously received organ or bone marrow transplantation. 3. Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA\> 2000 IU/ml or 104 copies/ml; hepatitis C virus (HCV) antibody positive and HCV-RNA \>103 copies/ml;. Patients with acute or chronic active hepatitis B or C infection who have received nucleotide antiviral therapy and are below the above standards can be selected. 4. Uncontrollable hypertension, systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after best medical treatment, history of hypertensive crisis or hypertensive encephalopathy. 5. Pleural effusion, ascites, and pericardial effusion with clinical symptoms or requiring drainage , patients who only shows with a few pleural effusion, ascites, and pericardial effusion by imaging and with no clinical symptoms can be selected.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | up to 24 months | Investigator evaluated ORR per RECIST V1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival, PFS | up to 24 months | PFS is defined as the time from first treatment to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1), or death due to any cause. |
| duration of response, DoR | up to 24 months | Defined as the time from the first documented objective response to the first documented progressive disease or death of any cause, whichever occurs first; |
| disease control rate, DCR | up to 24 months | Defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD |
| Overall Survival,OS | up to 24 months | OS is defined as the time from enrollment to the date of death. |
Countries
China
Contacts
Primary ContactTengfei Zhou
Outcome results
None listed