CholangiocarcinomaNCT05215665
GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma
A study testing GEMOX Regimen, Lenvatinib and Toripalimab in people with Cholangiocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The clinical trial is designed to evaluate the safety and efficacy of GEMOX combined with targeted therapy and immunotherapy for patients with advanced cholangiocarcinoma, and screen the potential biomarkers Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- GEMOX Regimen, Lenvatinib and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2022to 15 Jan 2026
- Phase
- Interventional
- 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
- Male or female, 18 years old ≤ age ≤ 70 years old
- ECOG PS scores 0-1
- Expected survival time > 12 weeks
- Advanced cholangiocarcinoma confirmed by histopathology and/or cytology, locally advanced (inoperable) or distant metastasis, and with at least one measurable lesion that has not been locally treated (per RECIST 1.1 criteria)
- Not received any previous systemic or local treatment for the tumor
- Sufficient organ and bone marrow function
Who cannot join
- Suffered from other malignant tumors in the past 5 years (except Radical basal cell carcinoma of the skin squamous carcinoma of the skin and/or radical resected carcinoma in situ)
- Ampullary tumor
- Received treatment from other clinical trials within 4 weeks before the first dose
- Received any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy
- Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, and myocardial infarction
- Uncontrollable pleural effusion, pericardial effusion or ascites
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- Use steroids or other systemic immunosuppressive therapies 4 weeks before enrollment
- Allergic reactions to the drugs used in this study
- HIV antibody positive, active hepatitis B or C (HBV, HCV)
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- other conditions that the investigator deems inappropriate for enrollment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality
Wei Lu, MD, +86 22-27468682, mail4luwei@163.com
Ningning Zhang, MD, 15822153931, mail4ningning@163.com
About this study
Official title: Efficacy, Safety Evaluation and Biomarker Screening of GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma
The clinical trial is designed to evaluate the safety and efficacy of GEMOX combined with targeted therapy and immunotherapy for patients with advanced cholangiocarcinoma, and screen the potential biomarkers
- Conditions
- Cholangiocarcinoma
- Being tested
- GEMOX Regimen, Lenvatinib, Toripalimab
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEMOX RegimenDrug
Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W
LenvatinibDrug
8/12mg PO QD continuously
ToripalimabDrug
240mg IV d1 Q3W
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | GEMOX+Lenvatinib+Toripalimab Receives: Drug: GEMOX Regimen; Drug: Lenvatinib; Drug: Toripalimab |
| group 2 | Experimental | GEMOX+Toripalimab Receives: Drug: GEMOX Regimen; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR
Measured: up to 90 days after last treatment administration
Secondary outcomes (4)
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR、PR or SD
Measured: up to 90 days after last treatment administration
Progression free survival (PFS)
the time period from randomization of the participants to objective tumor progression or death
Measured: up to 3 years
Overall survival (OS)
the time period from the randomization of the participants to the death event due to any reason
Measured: up to 3 years
The frequency, duration, and severity of adverse events
Safety is assessed by the frequency, duration, and severity of adverse events
Measured: up to 30 days after last treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start15 Jan 2022
- Primary completion15 May 2024
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215665
- Sponsor's protocol ID
- GTIC
- Status last verified
- May 2024
- First submitted
- 19 Jan 2022
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety Evaluation and Biomarker Screening of GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT05215665
- Acronym / sponsor ID
- GTIC
- Conditions
- Cholangiocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 31 Jan 2022 (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.
The clinical trial is designed to evaluate the safety and efficacy of GEMOX combined with targeted therapy and immunotherapy for patients with advanced cholangiocarcinoma, and screen the potential biomarkers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: GEMOX Regimen, Drug: Lenvatinib, Drug: ToripalimabGEMOX+Lenvatinib+Toripalimab |
| group 2 | Experimental | Drug: GEMOX Regimen, Drug: ToripalimabGEMOX+Toripalimab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, 18 years old ≤ age ≤ 70 years old
- ECOG PS scores 0-1
- Expected survival time > 12 weeks
- Advanced cholangiocarcinoma confirmed by histopathology and/or cytology, locally advanced (inoperable) or distant metastasis, and with at least one measurable lesion that has not been locally treated (per RECIST 1.1 criteria)
- Not received any previous systemic or local treatment for the tumor
Key exclusion criteria (11 listed)
- Suffered from other malignant tumors in the past 5 years (except Radical basal cell carcinoma of the skin squamous carcinoma of the skin and/or radical resected carcinoma in situ)
- Ampullary tumor
- Received treatment from other clinical trials within 4 weeks before the first dose
- Received any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy
- Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, and myocardial infarction
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 |
|---|---|---|
| GEMOX RegimenOxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W | Drug | group 1, group 2 |
| Lenvatinib8/12mg PO QD continuously | Drug | group 1 |
| Toripalimab240mg IV d1 Q3W | Drug | group 1, group 2 |
Primary outcome
Overall response rate (ORR)
Time frame: up to 90 days after last treatment administration
Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: up to 90 days after last treatment administration
Progression free survival (PFS)
Time frame: up to 3 years
Overall survival (OS)
Time frame: up to 3 years
The frequency, duration, and severity of adverse events
Time frame: up to 30 days after last treatment administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
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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 study testing GEMOX Regimen, Lenvatinib and Toripalimab in people with Cholangiocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 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 11 Dec 2024. 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.
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 Wei Liu, MD (+86 22-27468682, mail4luwei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: up to 90 days after last treatment administration). 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 11 Dec 2024.