Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrah… (NCT06208462) | Clinical Trial Compass
RecruitingPhase 2
Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors
China33 participantsStarted 2024-01-19
Plain-language summary
Clinical Study on the efficacy and safety of HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. The patient must sign the informed consent;
✓. Age 18-75 years old, male and female;
✓. ECOG Physical status Score (PS score) 0 or 1;
✓. Patients with ICC who have been pathologically diagnosed (histopathological and/or cytological examination) or clinically diagnosed as having high-risk factors;
✓. Patients with untreated and resectable locally advanced ICC who have been assessed by the surgeon as surgically resectable;
✓. The functional indicators of vital organs meet the following requirements
✓. The subject has at least one measurable lesion (according to RECIST1.1);
✓. Fertile women: must agree to abstain from sex (abstain from heterosexual intercourse) or use a reliable, effective method of contraception for at least 120 days from the signing of the informed consent until the final administration of the study drug. Serum HCG test must be negative within 72 hours before randomization. And must be non-lactating.A woman is considered fertile if she has menstruated, has not yet reached postmenopausal status (no continuous periods for ≥12 months, no cause other than menopause has been found), and has not undergone sterilization (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
Exclusion criteria
✕. Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma and other non-cholangiocarcinoma malignant tumor components;
✕
What they're measuring
1
Propotion of treatment completion
Timeframe: one year
Trial details
NCT IDNCT06208462
SponsorThe First Affiliated Hospital with Nanjing Medical University
. Prior systemic therapy and tumor-related surgical treatment (biliary drainage allowed);Patients who relapse after surgery, have received PD1 antibody, PDL1 antibody or CTLA4 antibody, Lenvatinib, chemotherapy in the past; participated in other clinical trials 30 days before screening
✕. Previous or co-existing malignancies other than adequately treated non-melanin skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;
✕. Active pulmonary tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year prior to enrollment; Had a history of active tuberculosis infection more than 1 year before enrollment, had not received formal anti-tuberculosis therapy or had active tuberculosis;
✕. Have an active, known, or suspected autoimmune disease. Subjects with hypothyroidism requiring hormone replacement therapy and skin conditions that do not require systemic therapy are eligible;
✕. Long-term acceptance of systemic sex hormones (doses equivalent to \> 10mg prednisone per day) or any other form of immunosuppressive therapy. Participants using inhaled or topical corticosteroids may be enrolled;
✕. Severe cardiopulmonary and renal dysfunction;
✕. Have hypertension that is not well controlled by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);