Cholangiocarcinoma, Intrahepatic Clinical Trial
Official title:
a Single-arm Study of Nab-Paclitaxel Combined With Gemcitabine Adjuvant Chemotherapy After Radical Resection of Intrahepatic Cholangiocarcinoma
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
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
Desai N, Trieu V, Yao Z, Louie L, Ci S, Yang A, Tao C, De T, Beals B, Dykes D, Noker P, Yao R, Labao E, Hawkins M, Soon-Shiong P. Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of cremophor-free, albumin-bound paclitaxel, ABI-007, compared with cremophor-based paclitaxel. Clin Cancer Res. 2006 Feb 15;12(4):1317-24. Erratum in: Clin Cancer Res. 2006 Jun 15;12(12):3869. Dosage error in article text. — View Citation
Frese KK, Neesse A, Cook N, Bapiro TE, Lolkema MP, Jodrell DI, Tuveson DA. nab-Paclitaxel potentiates gemcitabine activity by reducing cytidine deaminase levels in a mouse model of pancreatic cancer. Cancer Discov. 2012 Mar;2(3):260-269. doi: 10.1158/2159-8290.CD-11-0242. Epub 2012 Feb 28. — View Citation
Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. doi: 10.1200/JCO.2011.36.5742. Epub 2011 Oct 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | overall survival | the time from the day after surgery to death | 24 months | |
Primary | Disease-free survival | the time from the day after surgery to the recurrence of cancer. | 24 months | |
Secondary | safety: the potential side effects | the potential side effects | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04527679 -
Cisplatin and Gemcitabine Chemotherapy and Lenvatinib for Patients With Unresectable Intrahepatic Cholangiocarcinoma
|
Phase 2 | |
Terminated |
NCT03267940 -
Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
|
Phase 1 | |
Recruiting |
NCT04634058 -
PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment
|
Phase 2 | |
Active, not recruiting |
NCT03951597 -
Combined Therapy Using Oxaliplatin and Gemcitabine Chemotherapy, Lenvatinib and PD1 Antibody (JS001) for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma
|
Phase 2 | |
Completed |
NCT03377179 -
A Study of ABC294640 (Yeliva ®) Alone and in Combination With Hydroxychloroquine Sulfate in Treatment of Patients With Advanced Cholangiocarcinoma
|
Phase 2 | |
Active, not recruiting |
NCT04361331 -
Two-cohort Study of Toripalimab(PD1)+Lenvatnib, or Gemox+Lenvatinib in Advanced Intrahepatic Cholangiocarcinoma
|
Phase 2 | |
Completed |
NCT04072250 -
Surgery for Recurrent Intrahepatic Cholangiocarcinoma
|
||
Recruiting |
NCT05210322 -
Percutaneous Cholangiopancreatoscopy Registry
|
||
Recruiting |
NCT04782804 -
Adjuvant PD-1 Antibody in Combination With Capecitabine for Patients With ICC at High-Risk of Postoperative Recurrence
|
Phase 1/Phase 2 | |
Recruiting |
NCT04264260 -
Evaluation the Palliative Effects of Colchicine on Primary Hepatic Malignant Tumors Unable to Receive Curative Treatment
|
Phase 2 | |
Recruiting |
NCT06140134 -
Liver Transplantation in Intrahepatic Cholangiocarcinoma
|
||
Enrolling by invitation |
NCT04195503 -
Liver Transplant for Stable, Advanced Intrahepatic Cholangiocarcinoma
|
N/A | |
Recruiting |
NCT04506281 -
PD1 Antibody (Toripalimab), GEMOX and Lenvatinib Neoadjuvant Treatment for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors
|
Phase 2 | |
Recruiting |
NCT05124002 -
Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for Intrahepatic Cholangiocarcinoma
|
Phase 4 | |
Terminated |
NCT03316222 -
Study of GNS561 in Patients With Liver Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03405909 -
Standardized CEUS Algorithms for Diagnosis of HCC - Prospective German Multicenter Study
|
||
Recruiting |
NCT06381648 -
Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC)
|
||
Available |
NCT03414489 -
Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)
|