Biliary Tract CancerPhase 2NCT06490107
Durvalumab Combined With S-1 as Adjuvant Therapy of Resectable BTC
A Phase 2 study testing Durvalumab combined with S-1 in people with Biliary Tract Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The aim of this study is to assess the efficacy and safety of durvalumab combined with S-1 as adjuvant therapy of resectable Biliary Tract Cancer(BTC) with high risk of recurrence Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Durvalumab combined with S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2024to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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, both males and females are eligible.
- Intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer(Histologically confirmed).
- TNM stage before surgery: GBC/DCC T2-T4, N+, M0; ICC T1b-T4, N+, M0; PCC, any T, any N, M0 (according to UICC/AJCC TNM staging (8th edition)) .
- Patients must undergo radical resection, including liver resection or pancreatectomy, before enrollment.
- Time between surgery and enrollment < 12 weeks.
- R0 resection.
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- ECOG PS 0-1.
- No distant metastasis confirmed by MRI.
- Adequate organ and marrow function, as defined below. Haemoglobin ≥ 9 g/dL Absolute neutrophil count ≥ 1.5 × 109/L Platelet count ≥ 100 × 109/L Serum bilirubin ≤ 1.0 × ULN ALT and AST ≤ 2.5 × ULN Calculated creatinine clearance > 50 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance.
Who cannot join
- Patient diagnosed with Ampulla of Vater(AoV).
- Time between surgery and enrollment >12 weeks.
- Receive anti-tumor treatment before surgery, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, local therapy, etc.
- The tumor was not completely removed, or the postoperative pathology indicated that it was not a biliary tract tumor.
- Receive other anti-tumor treatments, such as chemotherapy, radiotherapy, or other research drugs, during postoperative adjuvant therapy.
- Severe infection within 4 weeks before enrollment.
- Participated in another interventional clinical study.
- Other factors deemed by the investigator to make the participant unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
About this study
Official title: A Single-arm, Single-center Study of Durvalumab Combined With S-1 as Adjuvant Therapy for Resectable Biliary Tract Cancer(BTC) With High Risk of Recurrence
The aim of this study is to assess the efficacy and safety of durvalumab combined with S-1 as adjuvant therapy of resectable Biliary Tract Cancer(BTC) with high risk of recurrence
Read the detailed description
Radical surgical resection is still the most important radical treatment for biliary tract tumors, and the postoperative recurrence rate of BTC patients remains high. It is particularly important to choose appropriate and effective adjuvant treatment.
This study is a single center, single arm, prospective, phase II clinical study. This study plans to include 40 BTC patients after radical resection. The patients are evaluated by a multidisciplinary team (MDT) as high risk of recurrence. Adjuvant therapy with durvalumab combined with S-1 should be started no more than 12 weeks after radical surgery. These patients will first receive 8 cycles of adjuvant therapy and the regimens consist of durvalumab and S-1, with a 21-day dosing cycle. After 8 cycles of adjuvant therapy, if the patients do not experience disease recurrence or intolerance，then the patients wil receive 6 cycles of adjuvant therapy in maintenance therapy stage. The regimen of andjuvant therapy is durvalumab with 28-day dosing cycle.
If the patients experience recurrence, the subsequent treatment plan will be determined by the researchers based on treatment guidelines.
- Conditions
- Biliary Tract Cancer
- Being tested
- Durvalumab combined with S-1
- Keywords
- Resectable Biliary Tract Cancer, High Risk of Recurrence, Adjuvant therapy, Immunotherapy combined with chemotherapy
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durvalumab combined with S-1Drug
Also called PD-L1+S-1
The treatment regimen for this study is as follows:
First 8 cycles of adjuvant therapy: Durvalumab 1500mg, (Day 1, IV, Q3W) and S-1 40mg/m2 (Day1-14, BID, Q3W), up to 8 cycles.
Maintenance therapy stage(6 cycles)：If the patients do not experience disease recurrence or intolerance after first 8 cycles of adjuvant therapy, then, Durvalumab 1500mg, (IV, Q4W), up to 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab combined with S-1 | Experimental | Durvalumab combined with S-1 Receives: Drug: Durvalumab combined with S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence-free survival rate
The 2-year recurrence-free survival rate refers to the proportion of patients who did not experience disease recurrence within 2 years after surgery.
Measured: 2 years
Secondary outcomes (4)
Overall survival（OS）
It is the time from the start of treatment to the death of the patient due to any cause.
Measured: 3 years
Recurrence-free survival(RFS)
It is the time from surgery to the earliest disease recurrence of the patient.
Measured: 2 years
3-year overall survival rate(3-year OS rate)
The proportion of patients who did not die with any cause within 3 years after receiving treatment.
Measured: 3 years
Safety and tolerability by incidence, severity and outcome of adverse events
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start24 May 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Yongkun Sun, Study chair, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490107
- Sponsor's protocol ID
- NCC4584
- Status last verified
- Jun 2024
- First submitted
- 29 Jun 2024
- Last updated
- 8 Jul 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center Study of Durvalumab Combined With S-1 as Adjuvant Therapy for Resectable Biliary Tract Cancer(BTC) With High Risk of Recurrence
- ClinicalTrials.gov ID
- NCT06490107
- Acronym / sponsor ID
- NCC4584
- Conditions
- Biliary Tract Cancer
- Keywords
- Resectable Biliary Tract Cancer, High Risk of Recurrence, Adjuvant therapy, Immunotherapy combined with chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 24 May 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 8 Jul 2024 (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 aim of this study is to assess the efficacy and safety of durvalumab combined with S-1 as adjuvant therapy of resectable Biliary Tract Cancer(BTC) with high risk of recurrence
Detailed description
Radical surgical resection is still the most important radical treatment for biliary tract tumors, and the postoperative recurrence rate of BTC patients remains high. It is particularly important to choose appropriate and effective adjuvant treatment.
This study is a single center, single arm, prospective, phase II clinical study. This study plans to include 40 BTC patients after radical resection. The patients are evaluated by a multidisciplinary team (MDT) as high risk of recurrence. Adjuvant therapy with durvalumab combined with S-1 should be started no more than 12 weeks after radical surgery. These patients will first receive 8 cycles of adjuvant therapy and the regimens consist of durvalumab and S-1, with a 21-day dosing cycle. After 8 cycles of adjuvant therapy, if the patients do not experience disease recurrence or intolerance，then the patients wil receive 6 cycles of adjuvant therapy in maintenance therapy stage. The regimen of andjuvant therapy is durvalumab with 28-day dosing cycle.
If the patients experience recurrence, the subsequent treatment plan will be determined by the researchers based on treatment guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab combined with S-1 | Experimental | Drug: Durvalumab combined with S-1Durvalumab combined with S-1 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years, both males and females are eligible.
- Intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer(Histologically confirmed).
- TNM stage before surgery: GBC/DCC T2-T4, N+, M0; ICC T1b-T4, N+, M0; PCC, any T, any N, M0 (according to UICC/AJCC TNM staging (8th edition)) .
- Patients must undergo radical resection, including liver resection or pancreatectomy, before enrollment.
- Time between surgery and enrollment < 12 weeks.
Key exclusion criteria (8 listed)
- Patient diagnosed with Ampulla of Vater(AoV).
- Time between surgery and enrollment >12 weeks.
- Receive anti-tumor treatment before surgery, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, local therapy, etc.
- The tumor was not completely removed, or the postoperative pathology indicated that it was not a biliary tract tumor.
- Receive other anti-tumor treatments, such as chemotherapy, radiotherapy, or other research drugs, during postoperative adjuvant therapy.
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 |
|---|---|---|
| Durvalumab combined with S-1Also: PD-L1+S-1The treatment regimen for this study is as follows: First 8 cycles of adjuvant therapy: Durvalumab 1500mg, (Day 1, IV, Q3W) and S-1 40mg/m2 (Day1-14, BID, Q3W), up to 8 cycles. Maintenance therapy stage(6 cycles)：If the patients do not experience disease recurrence or intolerance after first 8 cycles of adjuvant therapy, then, Durvalumab 1500mg, (IV, Q4W), up to 6 cycles | Drug | Durvalumab combined with S-1 |
Primary outcome
2-year recurrence-free survival rate
Time frame: 2 years
The 2-year recurrence-free survival rate refers to the proportion of patients who did not experience disease recurrence within 2 years after surgery.
4 secondary outcomes
Overall survival（OS）
Time frame: 3 years
Recurrence-free survival(RFS)
Time frame: 2 years
3-year overall survival rate(3-year OS rate)
Time frame: 3 years
Safety and tolerability by incidence, severity and outcome of adverse events
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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Not yet recruitingPhase 3
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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.
Yongkun Sun study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 combined with S-1 in people with Biliary Tract Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 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.
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?
This study is still under way. Results are not available in the source record yet.
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?
2-year recurrence-free survival rate (time frame: 2 years). 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 8 Jul 2024.