DurvalumabPhase 2NCT05672537
Durvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk
A Phase 2 study testing Durvalumab, Surgery and Gemcitabine in people with Durvalumab and Intrahepatic Cholangiocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study is a randomized controlled study to evaluate the efficacy and safety of Durvalumab combined with GemCis for neoadjuvant treatment of high recurrence risk ICC Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Durvalumab, Intrahepatic Cholangiocarcinoma, Gemcis
- What is being tested?
- Durvalumab, Surgery and Gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2023to 31 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18, male or female;
- Pathological diagnosis confirmed intrahepatic cholangiocarcinoma, which could be resected surgically; One of the following conditions shall be met:
- 2.1 Single tumor, diameter greater than 5cm (T1b) 2.2 Single tumor with vascular invasion (T2), multiple tumors ≤ 3 2.3 Tumor penetrating visceral peritoneum (T3) or directly invading surrounding organs (T4) 2.4 Suspicious lymph node metastasis in Zone 8, 12 or 13
- Can not received systemic treatment before participating in the study;
- ECOG PS score 0-1;
- The main organs function normally, and there is no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases.
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- Laboratory inspection shall meet the following requirements:
- Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug; For men, they should be surgically sterilized or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug.
- The patient voluntarily participated and signed the informed consent form;
- It is expected that the compliance is good, and the efficacy and adverse reactions can be followed up according to the requirements of the scheme.
Who cannot join
- Patients who received PD-1, PD-L1, PD-L2, CTLA-4 before enrollment, or directly received another stimulatory or co inhibitory T cell receptor (such as CTLA-4, 0X40, CD137);
- Any other research drugs within 4 weeks before enrollment;
- Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy);
- Congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection;
- Uncontrollable clinical cardiac symptoms or diseases, such as NYHA II and above heart failure unstable angina pectoris, myocardial infarction within one year, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
- Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first drug administration, or fever of unknown cause>38.5 ° C occurred during screening/before the first drug administration;
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- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Live attenuated vaccine shall be inoculated within 4 weeks before the first administration or planned during the study period;
- Suffered from or accompanied by other system malignant tumors in the last 5 years (except cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer);
- Allergic to any test drug;
- Pregnant and lactating women, fertile subjects are unwilling to take effective contraceptive measures;
- Uncontrollable psychosis;
- Other situations that the researcher thinks are not suitable for inclusion. If the patient has central nervous system metastasis, has serious laboratory examination abnormalities, and is accompanied by family or social factors, it will affect the safety of the subject, or the collection of data and samples.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Qiang WU, MD. Ph.D., 18622221080, wuqiangtianjin@hotmail.com
Qiang WU, MD. Ph.D.
About this study
Official title: Duvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk, Phase II, Single Center, Randomized Controlled Study
This study is a randomized controlled study to evaluate the efficacy and safety of Durvalumab combined with GemCis for neoadjuvant treatment of high recurrence risk ICC
- Conditions
- Durvalumab, Intrahepatic Cholangiocarcinoma, Gemcis
- Being tested
- Durvalumab, Surgery, Gemcitabine, Cisplatin
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
1500mg intravenous injection for 21d cycle
SurgeryProcedure or surgery
Surgery
GemcitabineDrug
gemcitabine 1000mg/m2, D1\&D8, 21d cycle.
CisplatinDrug
cisplatin 25mg/m2, D1\&D8, 21d cycle.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab Combined with GemCis Neoadjuvant Therapy Group | Experimental | Not described Receives: Drug: Durvalumab; Drug: Gemcitabine; Drug: Cisplatin |
| Surgical treatment group | Experimental | Not described Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year relapse free survival rate
Measured: 1-year
Secondary outcomes (8)
2-year relapse free survival rate
Measured: 2-year
ORR
Measured: 1-year
DCR
Measured: 1-year
R0 resection rate
Measured: 1-year
30 day postoperative complication rate
Measured: 30 day
Occurrence of adverse reactions
Measured: 1-year
1-year OS
Measured: 1-year
2-year OS
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start20 Jan 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DurvalumabStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672537
- Sponsor's protocol ID
- D20230101
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 5 Jan 2023
- 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 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk, Phase II, Single Center, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05672537
- Acronym / sponsor ID
- D20230101
- Conditions
- Durvalumab, Intrahepatic Cholangiocarcinoma, Gemcis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jan 2023 (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.
This study is a randomized controlled study to evaluate the efficacy and safety of Durvalumab combined with GemCis for neoadjuvant treatment of high recurrence risk ICC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Durvalumab Combined with GemCis Neoadjuvant Therapy Group | Experimental | Drug: Durvalumab, Drug: Gemcitabine, Drug: Cisplatin |
| Surgical treatment group | Experimental | Procedure: Surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18, male or female;
- Pathological diagnosis confirmed intrahepatic cholangiocarcinoma, which could be resected surgically; One of the following conditions shall be met:
- 2.1 Single tumor, diameter greater than 5cm (T1b) 2.2 Single tumor with vascular invasion (T2), multiple tumors ≤ 3 2.3 Tumor penetrating visceral peritoneum (T3) or directly invading surrounding organs (T4) 2.4 Suspicious lymph node metastasis in Zone 8, 12 or 13
- Can not received systemic treatment before participating in the study;
- ECOG PS score 0-1;
Key exclusion criteria (13 listed)
- Patients who received PD-1, PD-L1, PD-L2, CTLA-4 before enrollment, or directly received another stimulatory or co inhibitory T cell receptor (such as CTLA-4, 0X40, CD137);
- Any other research drugs within 4 weeks before enrollment;
- Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy);
- Congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection;
- Uncontrollable clinical cardiac symptoms or diseases, such as NYHA II and above heart failure unstable angina pectoris, myocardial infarction within one year, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
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 |
|---|---|---|
| Durvalumab1500mg intravenous injection for 21d cycle | Drug | Durvalumab Combined with GemCis Neoadjuvant Therapy Group |
| SurgerySurgery | Procedure or surgery | Surgical treatment group |
| Gemcitabinegemcitabine 1000mg/m2, D1\&D8, 21d cycle. | Drug | Durvalumab Combined with GemCis Neoadjuvant Therapy Group |
| Cisplatincisplatin 25mg/m2, D1\&D8, 21d cycle. | Drug | Durvalumab Combined with GemCis Neoadjuvant Therapy Group |
Primary outcome
1-year relapse free survival rate
Time frame: 1-year
8 secondary outcomes
2-year relapse free survival rate
Time frame: 2-year
ORR
Time frame: 1-year
DCR
Time frame: 1-year
R0 resection rate
Time frame: 1-year
30 day postoperative complication rate
Time frame: 30 day
Occurrence of adverse reactions
Time frame: 1-year
1-year OS
Time frame: 1-year
2-year OS
Time frame: 2-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
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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.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
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 Durvalumab, Surgery and Gemcitabine in people with Durvalumab and 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 10 inclusion and 13 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 5 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year relapse free survival rate (time frame: 1-year). 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 5 Jan 2023.