Brief Title
A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer
Official Title
A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer
Brief Summary
It is a trial to compare the efficacy and safety of Nab-paclitaxel plus Cisplatin vs
Gemcitabine plus Cispatin as first line chemotherapy in advanced biliary tract cancer.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
PFS
Secondary Outcome
ORR
Condition
Biliary Tract Cancer
Intervention
Nab-paclitaxel + Cisplatin
Study Arms / Comparison Groups
Nab-paclitaxel + Cisplatin
Description: Patients in this arm receive chemotherapy with Nab-paclitaxel plus Cisplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
100
Start Date
September 1, 2019
Completion Date
September 1, 2021
Primary Completion Date
March 1, 2021
Eligibility Criteria
Inclusion Criteria:
1. Aged 18 to 70 years;
2. Diagnosis of unresectable or recurrent or metastatic biliary tract cancer (Ampulla of
Vater, gallbladder, intra or extra-hepatic biliary ducts);
3. Adequate bone marrow, liver and kidney function: absdute neutrophil count (ANC) ≥ 1.5
x 10^9/L, platelet count (PLT) ≥75 x 10^9/L, hemoglobin (HB) ≥ 75 g/L, White blood
cell(WBC) ≥ 3.0 x 10^9/L, no bleeding symptoms or bleeding tendency; Total bilirubin
(TBIL) ≤ 3 x upper limit of normal range (ULN), alanine glutamate transaminase (ALT)
and glutamate transaminase (AST) ≤ 5 x upper limit of normal range (ULN);
creatinine(Cr) ≤ 1.5 x upper limit of normal range(ULN) or creatinine clearance
rate（CCR）≥ 45ml/min;
4. At least one measurable lesion;
5. Karnofsky Performance Status(KPS) ≥ 70;
6. Estimated life expectancy of at least 3 months;
7. Resolution of all acute clinical toxic effects of any prior treatment to grade ≤ 1,
with the exception of alopecia;
8. Be able to understand and willingness to sign IRB-approved informed consent; (If the
patient cannot sign the informed consent due to consciousness disorder, upper limbs
paralysis or inability to write, the legal representative shall sign the informed
consent on behalf of the patient).
Exclusion Criteria:
1. Ongoing uncontrolled infections, or have received systemic antibiotic therapy within
72 hours prior to registration;
2. Myeloproliferative disorder or any other hematopoietic function disorder;
3. Have an untreated second malignancy or brain metastasis;
4. Allergic to the chemotherapy drugs of this protocol;
5. Unable to cooperate due to neurologic diseases or psychiatric illness;
6. Pregnant or lactating female patients; Women of child-bearing age who refuse to accept
contraceptive measures;
7. Have other significant medical illness, for example,active tuberculosis, active
pneumonia, uncorrected electrolyte disturbance, uncontrolled tumor associated pain,
uncontrolled hydrothorax or seroperitoneum and so on;
8. Patients need to receive other antitumor therapy at the same time;
9. Have received any other experimental treatment or participated in another
interventional clinical trial within 30 days prior to registration;
10. Any other situation that the researcher considered patients are unsuitable for the
trial.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
, +8613006325115, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04692051
Organization ID
CSPC-KAL-BTC-03
Responsible Party
Principal Investigator
Study Sponsor
Huazhong University of Science and Technology
Collaborators
CSPC Ouyi Pharmaceutical Co., Ltd.
Study Sponsor
, ,
Verification Date
December 2020