Intrahepatic CholangiocarcinomaPhase 2NCT05251662
Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX in Advanced Intrahepatic Cholangiocarcinoma
A Phase 2 study testing Sintilimab, IBI305 and GEMOX in people with Intrahepatic Cholangiocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
A randomized controlled, phase II clinical trial is designed to compare the safety and efficacy of Sintilimab combined with GEMOX ± IBI305 and GEMOX as first-line therapy in advanced intrahepatic cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- Sintilimab, IBI305 and GEMOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2022to 13 Jan 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent should be signed before implementing any trial-related procedures
- Male or female, 18 years old ≤ age ≤ 75 years old
- Histopathologically or cytologically diagnosed as locally advanced intrahepatic cholangiocarcinoma
- No previous systemic treatment, More than 6 months after the end of postoperative adjuvant therapy was allowed
- Expected survival time > 3 months
- At least ≥ 1 measurable lesions per RECIST 1.1
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- ECOG PS scores 0-2
- Sufficient organ and bone marrow function
- Urine or serum pregnancy test is negative
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, 300060
Wei Lu, MD, +86 22-27468682, mail4luwei@163.com
Ningning Zhang, MD, 15822153931, mail4ningning@163.com
About this study
Official title: A Phase II Study of Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX as First-line Therapy in Patients With Advanced Intrahepatic Cholangiocarcinoma
A randomized controlled, phase II clinical trial is designed to compare the safety and efficacy of Sintilimab combined with GEMOX ± IBI305 and GEMOX as first-line therapy in advanced intrahepatic cholangiocarcinoma.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Sintilimab, IBI305, GEMOX
- Keywords
- Intrahepatic Cholangiocarcinoma, First-line Therapy, Sintilimab, IBI305, GEMOX
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
200mg IV d1 Q3W
IBI305Drug
Also called Bevacizumab Biosimilar
7.5mg/kg IV d1 Q3W
GEMOXDrug
Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W
| Study group | Role | What they receive |
|---|---|---|
| experimental group1 | Experimental | Sintilimab Combined With GEMOX + IBI305 Receives: Drug: Sintilimab; Drug: IBI305; Drug: GEMOX |
| experimental group2 | Experimental | Sintilimab Combined With GEMOX Receives: Drug: Sintilimab; Drug: GEMOX |
| Comparator | Active comparator | GEMOX Receives: Drug: GEMOX |
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
Adverse event
All grades of adverse events, all grades of treatment related adverse events, serious 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 posted23 Feb 2022
- Study start13 Jan 2022
- Primary completion13 Jan 2024 (estimated)
- Study completion13 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Lu, MD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251662
- Sponsor's protocol ID
- SGBICC
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 23 Feb 2022
- 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 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX as First-line Therapy in Patients With Advanced Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT05251662
- Acronym / sponsor ID
- SGBICC
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- Intrahepatic Cholangiocarcinoma, First-line Therapy, Sintilimab, IBI305, GEMOX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 13 Jan 2024 (estimated)
- Study completion
- 13 Jan 2025 (estimated)
- First posted
- 23 Feb 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.
A randomized controlled, phase II clinical trial is designed to compare the safety and efficacy of Sintilimab combined with GEMOX ± IBI305 and GEMOX as first-line therapy in advanced intrahepatic cholangiocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental group1 | Experimental | Drug: Sintilimab, Drug: IBI305, Drug: GEMOXSintilimab Combined With GEMOX + IBI305 |
| experimental group2 | Experimental | Drug: Sintilimab, Drug: GEMOXSintilimab Combined With GEMOX |
| Comparator | Active comparator | Drug: GEMOXGEMOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent should be signed before implementing any trial-related procedures
- Male or female, 18 years old ≤ age ≤ 75 years old
- Histopathologically or cytologically diagnosed as locally advanced intrahepatic cholangiocarcinoma
- No previous systemic treatment, More than 6 months after the end of postoperative adjuvant therapy was allowed
- Expected survival time > 3 months
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 |
|---|---|---|
| Sintilimab200mg IV d1 Q3W | Drug | experimental group1, experimental group2 |
| IBI305Also: Bevacizumab Biosimilar7.5mg/kg IV d1 Q3W | Drug | experimental group1 |
| GEMOXOxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W | Drug | Comparator, experimental group1, experimental group2 |
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
Adverse event
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 23 Feb 2022.
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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.
Wei Lu, MD principal investigator
Tianjin Medical University Cancer Institute and Hospital
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 Sintilimab, IBI305 and GEMOX in people with Intrahepatic 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 9 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 23 Feb 2022. 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 Wei Lu, 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 23 Feb 2022.