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

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

1. The patient must have good compliance, be understood the research process of this study and required to sign an informed consent form;

2. age 18-75 years old, male or female;

3. Histopathologically confirmed intrahepatic cholangiocarcinoma，excluding mixed liver cancer;

4. The longest diameter of a single tumor in patients before surgery is 3~9cm. If the number of multiple tumors is ≤3, the total diameter≤9cm, maximum diameter ≤5cm;

5. Study treatment can be started within 4~6 weeks after R0 resection;

6. Except for R0 resection, no other anti-tumor treatment has been received;

7. No distant transfer；

8. ECOG<2, or KPS>70；

9. Bone marrow function criteria: hemoglobin (HGB)≥90g/L; absolute neutrophil count (ANC)≥1.5×109/L; platelets (PLT)≥100×109/L;

10. Liver function criteria: ALT, AST≤5×ULN, serum total bilirubin<3×ULN;

11. Renal function criteria: creatinine clearance > 45 mL/min

12. Prothrombin time <14s; (no anticoagulant therapy);

13. Patients without biliary obstruction who require biliary stent implantation must be completed at least 7 days prior to enrollment;

14. Non-lactating or pregnant women, contraception during or after 6 months of treatment.

15. No contraindications for gemcitabine and Nab-paclitaxel.

Exclusion Criteria:

1. Those patients who are allergic to the chemotherapy drugs and their components in this study

2. Patients with other malignant tumors within 5 years (except for cured carcinoma in situ or basal cell carcinoma of the skin)

3. Concomitant diseases that may interfere with treatment studies: such as severe infections, HIV-positive, clinically severe (ie active) Heart disease, uncontrolled epilepsy, central nervous system disease, or history of mental disorders;

4. Intraoperative or postoperative pathology determines patients who do not meet radical resection;

5. Patients with current or previous ≥ grade II peripheral neuropathy;

6. Patients who participated in other clinical studies within 4 weeks prior to enrollment;

7. Patients who has undergone organ transplantation;

8. Patients considered by the investigator not suitable for this trial.