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

NCT ID: NCT04692051

Last Updated: 2020-12-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-09-01

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.

Conditions

Biliary Tract Cancer

Keywords

Nab-paclitaxel + Cisplatin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nab-paclitaxel + Cisplatin

Patients in this arm receive chemotherapy with Nab-paclitaxel plus Cisplatin

Group Type: EXPERIMENTAL

Nab-paclitaxel + Cisplatin

Intervention Type: DRUG

Nab-paclitaxel 125mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.

Gemcitabine + Cisplatin

Patients in this arm receive chemotherapy with Gemcitabine plus Cisplatin

Group Type: ACTIVE_COMPARATOR

Gemcitabine + Cisplatin

Intervention Type: DRUG

Gemcitabine1000mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.

Interventions

Nab-paclitaxel + Cisplatin

Nab-paclitaxel 125mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.

Intervention Type: DRUG

Gemcitabine + Cisplatin

Gemcitabine1000mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xianglin Yuan

Professor, Head of the cancer center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liang Zhuang, professor

Role: CONTACT

Phone: +8613006325115

Email: mrzhuangliang@126.com

Facility Contacts

Liang Zhuang, professor

Role: primary

References

Yang X, Dai YH, Peng H, Zhang MS, Fu Q, Liu SF, Sun L, Zou YM, Xu HS, Qiu P, Qiu H, Huang Q, Cheng HH, Zhuang L. Nab-paclitaxel plus cisplatin versus gemcitabine plus cisplatin as first-line treatment in advanced biliary tract cancer: results of a multicentre, randomised, phase II trial. BMC Cancer. 2025 Aug 16;25(1):1321. doi: 10.1186/s12885-025-14581-3.

Reference Type: DERIVED

PMID: 40819029 (View on PubMed)

Other Identifiers

CSPC-KAL-BTC-03

Identifier Type: -

Identifier Source: org_study_id