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Biliary Tract CarcinomaPhase 2NCT04984980

Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Unresectable Biliary Tract Cancer

A Phase 2 study testing Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in people with Biliary Tract Carcinoma and Initially Unresectable, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Study design: Prospective, single-arm, single-center phase II clinical study; Primary endpoint: Conversion rate; Secondary endpoints: Safety, disease control rate, disease-free survival, and overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
1 Aug 2020to Jul 2023
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 and ≤80 years;
  • ECOG 0~1;
  • Histologically or cytologically confirmed carcinoma of the bile duct or gallbladder;
  • Imaging assessment of disease stage III/IVA/any TN1M0*;
  • The main organs have good functions and the examination indexes meet the following requirements:
  • Blood routine test:
Show all 11Show fewer
  • Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophils count ≥1.5×10^9/L; Platelet count ≥80×10^9/L;
  • Biochemical tests:
  • Total bilirubin ≤2×ULN (upper limit of normal value); Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤ 2.5×ULN; Endogenous creatinine clearance rate ≥ 50 mL /min (Cockcroft-Gault formula);
  • Voluntarily signed the informed consent;
  • Good compliance and family members are willing to cooperate with follow-up.

Who cannot join

  • Other uncured malignancies;
  • Pregnant or lactating women, if the subject becomes pregnant during the study period, should withdraw from the clinical trial;
  • Previous anti-tumor therapy for the disease in this study;
  • Participated in other drug clinical trials within one month;
  • Patients with known history of other systemic serious diseases before screening;
  • Long-term unhealed wounds or incomplete healed fractures;
Show all 11Show fewer
  • Have a history of organ transplantation;
  • Abnormal blood coagulation, with bleeding tendency (14 days before randomization must meet: INR within the normal range without the use of anticoagulants); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; The use of low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (not more than 100 mg daily) for prophylactic purposes is permitted, provided that INR is less than 1.5;
  • The incidence of arterial/venous thrombosis events in the previous year, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism, was screened;
  • People with a history of psychotropic substance abuse and unable to get rid of it or with mental disorders; Have a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
  • 12. Concomitant diseases that, in the Investigator's judgment, seriously endanger patient safety or affect patient completion of the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

Other trials in China

About this study

Official title: Efficacy and Safety of the Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Initially Unresectable Biliary Tract Cancer

Study design: Prospective, single-arm, single-center phase II clinical study; Primary endpoint: Conversion rate; Secondary endpoints: Safety, disease control rate, disease-free survival, and overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer; Interventions: Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab; Sample size: 34 patients; Treatment until: 1. successfully conversed to resectable disease 2. progressed disease 3. intolerable toxicity 4. patient requests withdrawal; Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 3 weeks of treatment, up to surgical treatment or disease progression; Safety evaluation: Evaluate adverse reactions according to CTCAE 4.0; Follow up: 12 months after the last case was enrolled.

Being tested
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combination of Gemcitabine, Oxaliplatin, Sintilimab and BevacizumabDrug

    Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab

Study groups in NCT04984980
Study groupRoleWhat they receive
combined treatment groupExperimentalCombination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab Gemcitabine: 1000mg/m^2, iv, d1, d8, q3w Oxaliplatin: 100mg/m^2, iv, d1, q3w Sintilimab: 200mg, iv, d1, q3w Bevacizumab: 5mg/kg, d1, q3w
Receives: Drug: Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. objective response rate

    objective response rate

    Measured: 3 weeks

Secondary outcomes (4)

  1. Safety：the incidence of adverse events and serious adverse events

    Incidence of adverse events and serious adverse events

    Measured: 3 weeks

  2. disease control rate

    disease control rate

    Measured: 3 weeks

  3. progress-free survival

    progress-free survival

    Measured: 3 weeks

  4. overall survival

    overall survival

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2021
  2. Study start1 Aug 2020
  3. Primary completionJul 2023 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04984980
Sponsor's protocol ID
2020-176-2096
Status last verified
Jan 2023
First submitted
26 Jul 2021
Last updated
26 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in people with Biliary Tract Carcinoma and Initially Unresectable, run by Fudan University 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 11 inclusion and 11 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 26 Jan 2023. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (time frame: 3 weeks). 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 NCT04984980.

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 26 Jan 2023.

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