NCT04077983

Nab-Paclitaxel Combined With Gemcitabine Adjuvant Chemotherapy After Radical Resection of Intrahepatic Cholangiocarcinoma

a Single-arm Study of Nab-Paclitaxel Combined With Gemcitabine Adjuvant Chemotherapy After Radical Resection of Intrahepatic Cholangiocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this phase 2 study, we aim to evaluate the effects and safety of combined therapy using nab-paclitaxel and gemcitabine chemotherapy for patients after radical resection of Intrahepatic Cholangiocarcinoma

Detailed description

Most patients with intrahepatic cholangiocarcinoma (ICC) are often accompanied by local or distant metastases and lose the opportunity for surgical resection. Surgical resection is the only effective means for long-term survival of patients with intrahepatic cholangiocarcinoma. However, multiple tumors, lymph node metastasis, and vascular invasion significantly reduced postoperative survival. Most patients will relapse due to less clinical data. The best adjuvant treatment strategy and standard protocol for patients with intrahepatic cholangiocarcinoma has not been determined. Current treatment options include chemotherapy based on fluoropyrimidine or gemcitabine. Albumin-bound paclitaxel(nab-paclitaxel) has been used to treat a variety of malignancies such as non-small cell lung cancer, pancreatic cancer, breast cancer, melanoma, ovarian cancer and the like. In the field of pancreatic cancer, studies have confirmed that albumin-bound paclitaxel has synergistic effects with gemcitabine. The combination of gemcitabine alone significantly increased the intratumoral concentration of gemcitabine. Albumin-bound paclitaxel plus gemcitabine is the first choice for first-line treatment of pancreatic cancer, but clinical studies in the field of cholangiocarcinoma are very limited. Based on the same origin of pancreatic and biliary embryos, biological behavior and pathological similarities. Therefore, in this second phase of the study, our aim was to evaluate the efficacy and safety of chemotherapy with nab-paclitaxel and gemcitabine in the prevention of postoperative recurrence in patients with intrahepatic cholangiocarcinoma.

Conditions

• Cholangiocarcinoma, Intrahepatic

Interventions

Type	Name	Description
DRUG	combined therapy using nab-paclitaxel and gemcitabine chemotherapy	1. Day1 nab-paclitaxel 125mg/m2, Day8 nab-paclitaxel 125mg/m2 2. Day1 gemcitabine 1000mg/m2, Day8 gemcitabine 1000mg/m2 3. Three weeks is a course of treatment with a total of 4 courses.

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-09-01
• Completion: 2022-09-01
• First posted: 2019-09-04
• Last updated: 2019-09-04