Biliary Tract CancerPhase 2NCT04692051
A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer
A Phase 2 study testing Nab-paclitaxel + Cisplatin and Gemcitabine + Cisplatin in people with Biliary Tract Cancer, run by Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Nab-paclitaxel + Cisplatin and Gemcitabine + Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Liang Zhuang, professor, +8613006325115, mrzhuangliang@126.com
About this study
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
- Being tested
- Nab-paclitaxel + Cisplatin, Gemcitabine + Cisplatin
- Keywords
- Nab-paclitaxel + Cisplatin
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxel + CisplatinDrug
Nab-paclitaxel 125mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.
Gemcitabine + CisplatinDrug
Gemcitabine1000mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Nab-paclitaxel + Cisplatin | Experimental | Patients in this arm receive chemotherapy with Nab-paclitaxel plus Cisplatin Receives: Drug: Nab-paclitaxel + Cisplatin |
| Gemcitabine + Cisplatin | Active comparator | Patients in this arm receive chemotherapy with Gemcitabine plus Cisplatin Receives: Drug: Gemcitabine + Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS is defined as time from the start of treatment to progression of disease or death.
Measured: up to 3 years
Secondary outcomes (4)
ORR
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Measured: up to 3 years
OS
Overall survival is defined as time from the start of treatment until death due to any reason.
Measured: up to 3 years
TTP
Time to progress is defined as time from randomized grouping to objective progression of tumors.
Measured: up to 3 years
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.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Sep 2019
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Xianglin Yuan, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692051
- Sponsor's protocol ID
- CSPC-KAL-BTC-03
- Status last verified
- Dec 2020
- First submitted
- 29 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40819029
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT04692051
- Acronym / sponsor ID
- CSPC-KAL-BTC-03
- Conditions
- Biliary Tract Cancer
- Keywords
- Nab-paclitaxel + Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nab-paclitaxel + Cisplatin | Experimental | Drug: Nab-paclitaxel + CisplatinPatients in this arm receive chemotherapy with Nab-paclitaxel plus Cisplatin |
| Gemcitabine + Cisplatin | Active comparator | Drug: Gemcitabine + CisplatinPatients in this arm receive chemotherapy with Gemcitabine plus Cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nab-paclitaxel + CisplatinNab-paclitaxel 125mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days. | Drug | Nab-paclitaxel + Cisplatin |
| Gemcitabine + CisplatinGemcitabine1000mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days. | Drug | Gemcitabine + Cisplatin |
Primary outcome
PFS
Time frame: up to 3 years
PFS is defined as time from the start of treatment to progression of disease or death.
4 secondary outcomes
ORR
Time frame: up to 3 years
OS
Time frame: up to 3 years
TTP
Time frame: up to 3 years
AEs
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Derived from this study: PubMed 40819029Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab-paclitaxel + Cisplatin and Gemcitabine + Cisplatin in people with Biliary Tract Cancer, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang Zhuang, professor (+8613006325115, mrzhuangliang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04692051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.