Not Yet RecruitingPhase 4

Lenvatinib and Adebrelimab Combined With GEMOX in the Perioperative Treatment of Potentially Resectable Intrahepatic Cholangiocarcinoma

China20 participantsStarted 2024-05-30

Plain-language summary

A single-arm, prospective clinical study was conducted to enroll 20 subjects. Each subject was treated with oral Lenvatinib + Adebrelimab + GEMOX (gemcitabine + oxaliplatin). The treatment phase before surgery was 3 cycles, and the evaluation was performed every 2 cycles. The evaluation was repeated before surgery, and the decision of surgery was made according to the evaluation results. To evaluate the efficacy and safety of Lenvatinib and Adebrelimab combined with GEMOX in the perioperative treatment of potentially resectable intrahepatic cholangiocarcinoma.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. hemoglobin ≥9g/dL
✓. absolute neutrophil count ≥1.5 × 109/L
✓. platelet count ≥ 100 × 109/L
✓. serum bilirubin ≤2.0× upper limit of normal (ULN); This condition does not apply to patients with proven Gilbert's syndrome. Any clinically significant biliary obstruction had to be relieved prior to enrollment in the study.
✓. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be ≤2.5×ULN. For patients with liver metastases, ALT and AST should be ≤5 × ULN.

What they're measuring

ORR

Timeframe: through study completion, an average of 1 year

DFS

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT06417606

SponsorZhiyong Huang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-20

Contact for this trial

Zunyi Zhang

86-15827413728 zunyizhangtjmu@163.com

View on ClinicalTrials.gov More Intrahepatic Cholangiocarcinoma trials