IBI310 in Combination With Sintilimab in Patients With Advanced Biliary Tract Cancer
Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Dec 13, 2022
Trial Information
Current as of January 16, 2025
Recruiting
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.
About Innovent Biologics (Suzhou) Co. Ltd.
Innovent Biologics (Suzhou) Co., Ltd. is a leading biotechnology company dedicated to the development and commercialization of innovative biologic therapies for the treatment of cancer, autoimmune diseases, and other serious conditions. Founded in 2011, Innovent focuses on the discovery and development of monoclonal antibodies and other biologic agents, leveraging advanced technology platforms to address unmet medical needs. With a strong commitment to research and development, the company collaborates with international partners and healthcare professionals to bring cutting-edge therapeutics to market, ultimately improving patient outcomes and quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Changsha, Hunan, China
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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