IBI310 in Combination With Sintilimab in Patients With Advanced Biliary Tract Cancer

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with advanced biliary tract cancer, which is a type of cancer that affects the bile ducts and gallbladder. The trial is specifically looking at whether a combination of two medications, IBI310 and Sintilimab, can help improve outcomes for patients whose cancer has progressed despite previous treatments. The study is currently seeking participants aged 18 and older who have advanced biliary tract cancer that cannot be surgically removed and have experienced cancer progression after at least one prior treatment.

To be eligible for this trial, individuals must not have received certain types of immunotherapy before and should have at least one measurable area of cancer that can be monitored during the study. Participants in this trial can expect to receive the combination treatment and will be closely monitored by the research team throughout the process. It’s important for potential participants to understand that they will need to provide informed consent and be able to attend regular visits as part of the study. Overall, this trial aims to explore new possibilities for treating a challenging and often advanced form of cancer.

Gender

ALL

Eligibility criteria

• 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.