Biliary Tract CarcinomaPhase 1/2NCT04979663
GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer
A Phase 1/2 study testing Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab in people with Biliary Tract Carcinoma, run by Fudan University at 1 site in China.
Trial summary
Study design: Prospective, single-arm, single-center study; Primary endpoint: Safety; Secondary endpoints: Disease control rate, overall response rate, conversion rate, overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer; Interventions: Combination of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Tract Carcinoma
- What is being tested?
- Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to Jun 2022
- Phase
- Phase 1/2
- 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 years and ≤80 years;
- ECOG physical condition score: 0~1;
- Histologically or cytologically confirmed malignant tumor of epithelial origin in the biliary system;
- Preoperative imaging assessment of the disease stage was III/IV;
- The main organs function well, and the examination indicators meet the following requirements:
- Routine blood tests: Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophil count ≥1.5×10^9/L; Platelet count ≥80×10^9/L; Biochemical examination: Total bilirubin ≤2×ULN (upper normal value); ALT or AST ≤ 2.5×ULN; Endogenous creatinine clearance ≥ 50 mL /min (Cockcroft-Gault formula); 6. Sign the informed consent voluntarily; 9. Good compliance, and family members willing to cooperate with follow-up.
Who cannot join
- Patients with other uncured malignant tumors;
- Pregnant or lactating women who are required to withdraw from the clinical trial if they become pregnant during the study period;
- Previous antitumor therapy for the disease in this study;
- Participated in clinical trials of other drugs within one month;
- Patients with a known history of other systemic serious diseases before screening;
- Long-term unhealed wounds or incomplete healing fractures;
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- Previous organ transplantation history;
- Abnormal coagulation function;
- Screening for overactivity/venous thrombosis events in the previous year, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
- Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders;
- A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Lu Wang, M.D., +86-18121299357, w.lr@hotmail.com
About this study
Official title: Safety and Efficacy of GEMOX Combined With Donafenib and Tislelizumab as First-line Treatment in Biliary Tract Cancer
Study design: Prospective, single-arm, single-center study; Primary endpoint: Safety; Secondary endpoints: Disease control rate, overall response rate, conversion rate, overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer; Interventions: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab; Sample size: 10 patients;
Treatment until:
Read more
- successfully conversed to resectable disease
- progressed disease
- intolerable toxicity
- patient requests withdrawal Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 2 circles of treatment (6 weeks), 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.
- Conditions
- Biliary Tract Carcinoma
- Being tested
- Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Gemcitabine, Oxaliplatin, Donafenib and TislelizumabCombination product
Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Combination of Gemox, Donafenib and Tislelizumab Receives: Combination Product: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: the incidence of adverse events and serious adverse events
Incidence of adverse events and serious adverse events
Measured: 3 weeks
Secondary outcomes (4)
Disease control rate
Disease control rate
Measured: 6 weeks
Overall response rate
Overall response rate
Measured: 6 weeks
Conversion rate
Conversion rate
Measured: 6 weeks
Overall survival
Overall survival
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Dec 2020
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
- Investigators
- Lu Wang, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979663
- Sponsor's protocol ID
- 2021-07-2310
- Status last verified
- Jul 2021
- First submitted
- 27 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of GEMOX Combined With Donafenib and Tislelizumab as First-line Treatment in Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT04979663
- Acronym / sponsor ID
- 2021-07-2310
- Conditions
- Biliary Tract Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 28 Jul 2021 (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.
Study design: Prospective, single-arm, single-center study; Primary endpoint: Safety; Secondary endpoints: Disease control rate, overall response rate, conversion rate, overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer; Interventions: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab; Sample size: 10 patients;
Treatment until:
- successfully conversed to resectable disease
- progressed disease
- intolerable toxicity
- patient requests withdrawal Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 2 circles of treatment (6 weeks), 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Combination Product: Combination of Gemcitabine, Oxaliplatin, Donafenib and TislelizumabCombination of Gemox, Donafenib and Tislelizumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years and ≤80 years;
- ECOG physical condition score: 0~1;
- Histologically or cytologically confirmed malignant tumor of epithelial origin in the biliary system;
- Preoperative imaging assessment of the disease stage was III/IV;
- The main organs function well, and the examination indicators meet the following requirements:
Key exclusion criteria (12 listed)
- Patients with other uncured malignant tumors;
- Pregnant or lactating women who are required to withdraw from the clinical trial if they become pregnant during the study period;
- Previous antitumor therapy for the disease in this study;
- Participated in clinical trials of other drugs within one month;
- Patients with a known history of other systemic serious diseases before screening;
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 |
|---|---|---|
| Combination of Gemcitabine, Oxaliplatin, Donafenib and TislelizumabCombination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 3 weeks | Combination product | experimental group |
Primary outcome
Safety: the incidence of adverse events and serious adverse events
Time frame: 3 weeks
Incidence of adverse events and serious adverse events
4 secondary outcomes
Disease control rate
Time frame: 6 weeks
Overall response rate
Time frame: 6 weeks
Conversion rate
Time frame: 6 weeks
Overall survival
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
Related trials for Biliary Tract Carcinoma
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
Advanced Biliary Tract Carcinoma
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.
Lu Wang, M.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab in people with Biliary Tract Carcinoma, 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 6 inclusion and 12 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 9 Aug 2021. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Lu Wang, M.D. (+86-18121299357, w.lr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: the incidence of adverse events and serious adverse events (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2021.