Cholangiocarcinoma
Conditions
Interventions
Experimental group:Toripalimab, 240mg, IV, q3w
Lenvatinib, 8mg, qd, po, with body weight < 60 kg, or 12 mg, qd, po, with body weight = 60 kg.
Until disease progression or intolerable adverse reactions or treatment for 1 year.
Sponsors
Tianjin Third Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Gender: male or female; 2. Age: 18 ~ 85 years old; 3. Patients with unresectable perihilar cholangiocarcinoma (including local unresectable, extrahepatic metastasis) with systemic treatment-naïve and patients with postoperative recurrence of perihilar cholangiocarcinoma that cannot be cured; confirmed by imaging examinations such as contrast-enhanced CT and MRCP; 4. Patients refused to receive standard treatment (chemotherapy); 5. At least one measurable lesion according to RECIST1.1 criteria; 6. After biliary stent implantation, TBiL = 80 points; 8. Expected survival time >= 3 months; 9. Bone marrow function: ANC >= 1.5 × 10^9/L, HB >= 90 g/L (blood transfusion allowed), PLT >= 80 × 10^9/L; 10.Liver function: ALT = 60 ml/min/1.73 m^2; 12.International normalized prothrombin time/partial thromboplastin time (PT-INR/PTT) <= 1.5 × ULN.Criteria for serum sodium, potassium, calcium, and magnesium levels <= Grade 1 (NCI-CTCAE (version 5.0)); 13.ECG showed QTc interval <= 480 ms; 14.No history of autoimmune diseases and current autoimmune diseases; 15.Subjects must have given informed consent to the study prior to the trial and voluntarily signed a written informed consent form; 16.Subjects are able to communicate well with the investigator and able to complete the study as specified in the protocol.
Exclusion criteria
Exclusion criteria: The patients who meet one of the following conditions cannot be enrolled in this trial 1) Participating in other clinical trials or using other investigational drugs or devices within 4 weeks of the first treatment. 2) Diagnosis of immunodeficiency or systemic steroid therapy required (> 10 mg prednisone, or other equivalent doses of hormonal agents) at the first treatment; 3) Patients who had received anti-tumor monoclonal antibody therapy or failed to recover from adverse reactions caused by anti-tumor monoclonal antibody therapy 4 weeks before the first treatment. 4) Previously had active tuberculosis. 5) Previous history of malignant tumor treatment, except basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma; 6) Combined with severe uncontrolled medical diseases such as severe diabetes, severe hypertension, severe infection, congestive heart failure, ventricular fibrillation, coronary heart disease with obvious symptoms or myocardial infarction in the past 6 months; 7) Hematologic premalignant diseases, such as myelodysplastic syndrome. 8) Clinically relevant or previous interstitial lung disease, such as non-infectious pneumonia or pulmonary fibrosis or baseline chest CT scan or chest X-ray found evidence of interstitial lung disease; 9) Previous or physical examination found central nervous system diseases, except for adequately treated (such as primary brain tumors, seizures not controlled by standard drug therapy or stroke); 10) Pre-existing neuropathy > Grade 1 (NCI CTCAE); 11) Allogeneic transplantation requires immunosuppressive therapy or other major immunosuppressive therapy. 12) Severe unhealed wounds, ulcers or fractures. 13) Patients with active autoimmune diseases requiring systemic treatment within the past 2 years; 14) Past pneumonitis, steroid therapy, or active pneumonia; Have interstitial lung disease. 15) Patients with active infection requiring systemic treatment; 16) Others: history of allergy to similar drugs, pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Quality of life score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;3, 6, 9, 12 months Overall Survival rates; | — |
Countries
China
Contacts
Public ContactCheng Lou
Tianjin Third Central Hospital
Outcome results
None listed