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

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04692051
• Other study ID #: CSPC-KAL-BTC-03
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: December 2020
• Source: Huazhong University of Science and Technology
• Contact: Liang Zhuang, professor
• Phone: +8613006325115
• Email: mrzhuangliang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• Nab-paclitaxel + Cisplatin
Nab-paclitaxel 125mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.
• Gemcitabine + Cisplatin
Gemcitabine1000mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	PFS is defined as time from the start of treatment to progression of disease or death.	up to 3 years
Secondary	ORR	The rate of participants that achieve either a complete response (CR) or a partial response (PR).	up to 3 years
Secondary	OS	Overall survival is defined as time from the start of treatment until death due to any reason.	up to 3 years
Secondary	TTP	Time to progress is defined as time from randomized grouping to objective progression of tumors.	up to 3 years
Secondary	AEs	Adverse reactions refer to the occurrence and development of diseases in the process of using drugs according to normal usage and dosage to prevent, diagnose or treat diseases.Adverse reactions unrelated to the purpose of treatment.	up to 3 years