A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer

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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