Department of Hepatobiliary Pancreatic Surgery, Fujian Provincial Hospital

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This is a prospective, single-arm, multicenter, phase II trial to evaluate the efficacy and safety of D-TACE-HAIC (GEMOX protocol) in combination with Envafolimab and Lenvatinib for unresectable intrahepatic cholangiocarcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 1\. Ages of 18 and 75;

• 2\. Child-Pugh liver function grade: A/B;

• 3\. ECOG score (see annex for scoring standards) : ≤1 score;

• 4\. ICC was confirmed by pathology and evaluated by two senior hepatobiliary surgeons as unresectable for surgery (including multiple intrahepatic lesions, local vascular invasion, local lymph node metastasis, and distant metastasis);

• 5\. According to RECIST 1.1 criteria, the patient has at least one measurable lesion (the CT/MRI scan diameter of the lesion can be measured ≥10mm, and the lesion has not received local treatment such as radiotherapy or freezing);

• 6\. The expected survival time is greater than 3 months;

• 7\. Patients who had not received any tumor-related targeting, immunization, radiotherapy or chemotherapy before enrollment;

• 8\. Functional indexes of vital organs met the following requirements: · Routine blood: absolute neutrophil count ≥1.5×109/L, Hb≥9.0g/L, PLT≥75×109/L; · Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN) (≤2.5 times ULN after biliary drainage in patients with obstructive jaundice); Alanine aminotransferase (ALT), aspartate aminotransferase (AST)≤ 5x ULN, albumin ≥30g /L; · Renal function: serum creatinine ≤1.5mg/dL, creatinine clearance ≥60ml /min; · Coagulation function: International standardized ratio (INR) and activated partial thromboplastin time (APTT)≤1.5 times ULN;

• 9\. No history of severe arrhythmia or heart failure; No history of severe ventilation dysfunction or severe pulmonary infection;

• 10\. Women of childbearing age should agree to use contraception during the use of medication and for 6 months after the end of medication; Patients who had a negative serum or urine pregnancy test in the 7 days prior to study enrollment and must be non-lactating patients, men should consent to use contraception during the study period and for 6 months after the end of the study period.

Locations
Other Locations
China
Fujian Provincial Hospital
RECRUITING
Fuzhou
Contact Information
Primary
Maolin Yan, Doctor
yanmaolin74@163.com
15960066307
Backup
Junyi Wu, Doctor
1248087863@qq.com
15059162797
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 37
Treatments
Combination therapy group
Patients with unresectable cholangiocarcinoma were treated with D-TACE-HAIC (GEMOX regimen) combined with envafolimab and lenvatinib
Sponsors
Leads: Fujian Provincial Hospital

This content was sourced from clinicaltrials.gov