Advanced Biliary Tract Cancers
Conditions
Interventions
Treatment group:SHR-1701 (Rilafucept alfa) in Combination with Famitinib and GEMOX
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. Histopathologically confirmed biliary tract malignancy (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer), with at least one measurable lesion according to RECIST v1.1; 3. No prior systemic therapy (patients with disease progression within 6 months after adjuvant therapy are excluded); 4. ECOG performance status 0-1; 5. No active brain metastases; 6. Expected survival >= 3 months; 7. Adequate major organ function, meeting the following criteria: (1) ANC >= 1.5 x 10^9/L; (2) PLT >= 80 x 10^9/L; (3) Hb >= 90 g/L; (4) TBIL (total bilirubin) = 50 mL/min (Cockcroft-Gault formula); (7) LVEF (left ventricular ejection fraction) >= 50%; 8. Subjects voluntarily participate in this clinical trial, understand the study procedures, are able to provide written informed consent, are willing and expected to comply with the study protocol, and have good anticipated compliance for follow-up of efficacy and adverse events as required by the protocol; 9. Female subjects of childbearing potential or male subjects with female partners of childbearing potential must use effective contraceptive measures throughout the treatment period and for 6 months after treatment discontinuation.
Exclusion criteria
Exclusion criteria: 1.Presence of poorly controlled cardiac clinical symptoms or diseases, such as: (1) cardiac insufficiency = Class II according to the New York Heart Association (NYHA) criteria, or left ventricular ejection fraction (LVEF) 450 ms (male) or QTc >470 ms (female) (QTc interval calculated using Fridericia's formula; if QTc is abnormal, measurements may be repeated three times at 2-minute intervals and the average value used); 2.Hypertension that cannot be reduced to the normal range with antihypertensive medication (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg, based on the average of =2 blood pressure readings), although achievement of these parameters with antihypertensive therapy is permitted; history of hypertensive crisis or hypertensive encephalopathy; 3.Multiple factors affecting oral drug absorption (e.g., inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction, etc.); 4.Abnormal coagulation function (INR >1.5×ULN, APTT >1.5×ULN) with a bleeding tendency; 5.Frank hemoptysis or coughing up blood of half a teaspoon (2.5 mL) or more per day within 2 months prior to screening; 6.Thromboembolic events within 6 months before the start of study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.; 7.Current interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring corticosteroid therapy, or other pulmonary conditions that may interfere with the assessment and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) or severely impaired pulmonary function; radiation pneumonitis within the radiation field is permitted; active tuberculosis; 8.Active autoimmune disease or history of autoimmune disease with potential for relapse (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis); patients with skin conditions not requiring systemic treatment, such as vitiligo, psoriasis, alopecia, well-controlled type I diabetes mellitus on insulin therapy, or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients with asthma requiring bronchodilators for medical intervention cannot be included; patients with any of the following cannot be enrolled in this study:; 9.Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 14 days prior to signing the informed consent form (at doses >10 mg/day of prednisone or equivalent doses of other corticosteroids); 10.Uncontrolled infection at the time of screening; 11.Pregnant or breastfeeding women; Other patients deemed unsuitable for enrollment by the treating physician. 12.Other conditions deemed by the treating physician to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;During of response;Adverse Event (AE);Overall survival;disease control rate; | — |
Countries
China
Contacts
Public ContactYing Jie'er
Zhejiang Cancer Hospital
Outcome results
None listed