Status:
UNKNOWN
Nab-Paclitaxel Combined With Gemcitabine Adjuvant Chemotherapy After Radical Resection of Intrahepatic Cholangiocarcinoma
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Cholangiocarcinoma, Intrahepatic
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 Cholangiocar...
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 ...
Eligibility Criteria
Inclusion
- The patient must have good compliance, be understood the research process of this study and required to sign an informed consent form;
- age 18-75 years old, male or female;
- Histopathologically confirmed intrahepatic cholangiocarcinoma，excluding mixed liver cancer;
- 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;
- Study treatment can be started within 4\~6 weeks after R0 resection;
- Except for R0 resection, no other anti-tumor treatment has been received;
- No distant transfer；
- ECOG\<2, or KPS\>70；
- Bone marrow function criteria: hemoglobin (HGB)≥90g/L; absolute neutrophil count (ANC)≥1.5×109/L; platelets (PLT)≥100×109/L;
- Liver function criteria: ALT, AST≤5×ULN, serum total bilirubin\<3×ULN;
- Renal function criteria: creatinine clearance \> 45 mL/min
- Prothrombin time \<14s; (no anticoagulant therapy);
- Patients without biliary obstruction who require biliary stent implantation must be completed at least 7 days prior to enrollment;
- Non-lactating or pregnant women, contraception during or after 6 months of treatment.
- No contraindications for gemcitabine and Nab-paclitaxel.
Exclusion
- Those patients who are allergic to the chemotherapy drugs and their components in this study
- Patients with other malignant tumors within 5 years (except for cured carcinoma in situ or basal cell carcinoma of the skin)
- 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;
- Intraoperative or postoperative pathology determines patients who do not meet radical resection;
- Patients with current or previous ≥ grade II peripheral neuropathy;
- Patients who participated in other clinical studies within 4 weeks prior to enrollment;
- Patients who has undergone organ transplantation;
- Patients considered by the investigator not suitable for this trial.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04077983
Start Date
September 1 2019
End Date
September 1 2022
Last Update
September 4 2019
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