Inoperable malignant biliary tumors
Conditions
Interventions
treatment group:QL1706 combined with Donafenib and hepatic arterial infusion chemotherapy
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18-75 years old 2. Non resectable malignant tumors of the biliary tract, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, diagnosed by pathological organization/cytology; 3. ECOG PS score = 1.5 x 10^9/L, platelets >= 75 x 10^9/L, hemoglobin >= 90 g/L; -Serum creatinine = 50 mL/min (Cockcroft Gault formula); -Alanine transaminase (ALT) and aspartate transaminase (AST) = 20%; 9. Expected lifespan>3 months; 10. Women of childbearing age must undergo a serum pregnancy test within 7 days before enrollment, with a negative result, and agree to use reliable and effective contraception methods during the trial period and for 3 months after the last dose. For male participants whose partners are women of childbearing age, they must agree to use reliable and effective methods of contraception during the trial period and within 3 months after the last dose. Breastfeeding women cannot be included in the group; 11. Participants must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form. They are willing and able to comply with the visit, treatment plan, laboratory tests, and other research procedures outlined in the study plan.
Exclusion criteria
Exclusion criteria: 1. Rare histopathological types of cholangiocarcinoma confirmed by histology or cytology, such as ampulla carcinoma, small cell carcinoma, neuroendocrine tumor, sarcoma, and mucinous cystic tumor 2. Any previous or planned organ transplant; 3. Obstructive jaundice patients who did not experience the expected reduction in jaundice; 4. Subjects with other malignant tumors within the 5 years prior to enrollment, except for cured skin basal cell carcinoma or cervical carcinoma in situ; 5. Diagnosed or suspected symptomatic patients with active brain or meningeal metastases; 6. Have participated in another interventional clinical study within the past 3 months or planned to participate in another clinical study during the study period, or have participated in another clinical study simultaneously, unless it is an observational, non interventional study, or a follow-up period of an interventional study; 7. Evidence of other diseases that the researcher considers unsuitable for inclusion in the study, such as uncontrolled hypertension, active hemorrhagic disease, active or uncontrolled infection (>= CTCAE level 2 infection), active interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhea, mental illness or social condition, or history of allogeneic organ transplantation; 8. History of severe cardiovascular disease: NYHA class II or above heart failure, unstable angina, myocardial infarction, uncontrolled arrhythmia, or cerebrovascular accident within 12 months prior to administration; Echocardiography shows LVEF480ms (Fridericia method, if QTc is abnormal, the average of three consecutive measurements taken every 2 minutes); Poor control of hypertension (systolic blood pressure >= 150 mmHg and/or diastolic blood pressure >= 100 mmHg, based on the average of >= 2 measurements); History of hypertensive crisis or encephalopathy; 9. History of active primary immunodeficiency or human immunodeficiency virus; History of active autoimmune diseases or potential recurrence of autoimmune diseases within the past 2 years, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (excluding patients controlled by hormone replacement therapy); 10: Previous immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, TIGIT, LAG3 antibodies), immune checkpoint agonists (such as CD40, CD137, OX40 antibodies), or other immunotherapy targeting tumor immune mechanisms, in addition to therapeutic anti-tumor vaccines; 11. Currently using or having used immunosuppressive drugs within 14 days prior to the first administration of the investigational drug. Except for the following situations: (1) intranasal, inhaled, local, or topical steroids (e.g. intra-articular); (2) Systemic corticosteroid treatment with prednisone not exceeding 10 milligrams per day; (3) Prophylactic use of steroids to treat hypersensitivity reactions (e.g. medication before CT scan treatment); 12. Received attenuated live vaccine within 30 days prior to the first administration of the investigational drug. Attention: If enrolled, patients are not allowed to receive attenuated live vaccines within 30 days after receiving study drug treatment and after the last dose of study drug; 13. Mixed infection of HBV (HBsAg and/or anti HBcAb positive, detectable HBV DNA) and HCV (anti HCV antibody positive) or HBV and HDV (a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS;Disease Control Rate, DCR;Overall Survival, OS;Duration of Overall Response, DoR; | — |
Countries
China
Contacts
Public ContactMingzhi Hao
Fujian Cancer Hospital
Outcome results
None listed