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

NCT04692051 | Unknown Phase 2

• 1 other identifier: CSPC-KAL-BTC-03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• PFS

  PFS is defined as time from the start of treatment to progression of disease or death.

  up to 3 years

Secondary Outcomes (4)

• ORR

  up to 3 years

• OS

  up to 3 years

• TTP

  up to 3 years

• AEs

  up to 3 years

Study Arms (2)

Nab-paclitaxel + Cisplatin

EXPERIMENTAL

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

Drug: Nab-paclitaxel + Cisplatin

Gemcitabine + Cisplatin

ACTIVE COMPARATOR

Patients in this arm receive chemotherapy with Gemcitabine plus Cisplatin

Drug: Gemcitabine + Cisplatin

Interventions

Nab-paclitaxel + Cisplatin DRUG

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

Nab-paclitaxel + Cisplatin

Gemcitabine + Cisplatin DRUG

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

Gemcitabine + Cisplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 70 years;
• Diagnosis of unresectable or recurrent or metastatic biliary tract cancer (Ampulla of Vater, gallbladder, intra or extra-hepatic biliary ducts);
• 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;
• At least one measurable lesion;
• Karnofsky Performance Status(KPS) ≥ 70;
• Estimated life expectancy of at least 3 months;
• Resolution of all acute clinical toxic effects of any prior treatment to grade ≤ 1, with the exception of alopecia;
• 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).

You may not qualify if:

• Ongoing uncontrolled infections, or have received systemic antibiotic therapy within 72 hours prior to registration;
• Myeloproliferative disorder or any other hematopoietic function disorder;
• Have an untreated second malignancy or brain metastasis;
• Allergic to the chemotherapy drugs of this protocol;
• Unable to cooperate due to neurologic diseases or psychiatric illness;
• Pregnant or lactating female patients; Women of child-bearing age who refuse to accept contraceptive measures;
• 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;
• Patients need to receive other antitumor therapy at the same time;
• Have received any other experimental treatment or participated in another interventional clinical trial within 30 days prior to registration;
• Any other situation that the researcher considered patients are unsuitable for the trial.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40819029 DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Liang Zhuang, professor

CONTACT

+8613006325115; mrzhuangliang@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of the cancer center

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: December 31, 2020
• Study Start: September 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 31, 2020

Record last verified: 2020-12

Locations

CN (1)