Biliary Tract CancerNCT06171321
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma
A study testing S-1(Intravenous combined with oral) in people with Biliary Tract Cancer, run by Shanghai East Hospital at 1 site in China.
Trial summary
In recent years, circulating tumor DNA (ctDNA)had achieved encouraging results in monitoring recurrence and metastasis after surgery, and has potential clinical application value. The presence of ctDNA after surgery predicts very poor recurrence-free survival, whereas its absence predicts a low 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?
- S-1(Intravenous combined with oral)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- Dec 2023to 1 Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Patients with pathologically confirmed BTCs according to the UICC/AJCC TNM staging system (8th edition 2017) for stage II-III tumours. Patients eligible for radical resection of BTCs. No synchronous or metastatic malignant tumour found in other organs other than the primary tumor.
- 2) Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 ~ 2.
- 3）With expected survival of more than 12 months. 4) Radical operation performed.
Who cannot join
- 1) Patients with positive surgical margins and residual lesions after biliary tract tumor surgery.
- 2) Blood transfusion performed during operation or within 2 weeks before operation.
- 3) Have a history of other malignant tumors within 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma: A Prospective Clinical Trial
In recent years, circulating tumor DNA (ctDNA)had achieved encouraging results in monitoring recurrence and metastasis after surgery, and has potential clinical application value. The presence of ctDNA after surgery predicts very poor recurrence-free survival, whereas its absence predicts a low risk of recurrence. The benefit of adjuvant chemotherapy for ctDNA-positive patients is not well understood.
Read the detailed description
The results of the PRODIGE-12/ACCORD-18 study showed that, with a median follow-up of 47 months, the adjuvant chemotherapy arm did not lead to a significant improvement in recurrence-free survival (RFS) and overall survival (OS). Notably, the patients with gallbladder cancer experienced adjuvant chemotherapy significantly worse RFS and OS compared to those in the monitoring arm. ctDNA risk stratifies patients to guide adjuvant treatment decisions This study aimed to demonstrate that a escalation strategy of ctDNA guided adjuvant chemotherapy is superior to standard of care treatment as measured by 2 year disease free survival (DFS) in patients with stage II- III biliary tract cancers with minimal residual disease (MRD) (ctDNA positive).
- Conditions
- Biliary Tract Cancer
- Being tested
- S-1(Intravenous combined with oral)
- Keywords
- S-1, circulating tumor DNA (ctDNA)
- 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.
S-1(Intravenous combined with oral)Drug
Oral combined with intravenous S-1 for ctDNA-positive patients (escalating treatment strategy)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients testing negative for ctDNA treated using standard of care treatment | No intervention | Postoperative ctDNA-negative patients receive oral Teysuno (S-1) for adjuvant therapy。 |
| Group 2: Patients with a positive ctDNA test are treated with an escalation strategy | Experimental | Postoperative ctDNA-positive patients receive intravenous combined oral Teysuno (S-1) for adjuvant therapy。 Receives: Drug: S-1(Intravenous combined with oral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA guided adjuvant chemotherapy versus Translational sub study
To demonstrate the superiority of an escalation strategy of ctDNA-guided adjuvant chemotherapy over standard-of-care treatment, 2-year disease-free survival (DFS) was measured as 2-year Disease-Free Survival (DFS) in high-risk stage II-III BTC patients with no evidence of minimal residual disease (ctDNA-negative).
Measured: Up to 60 months
Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis
Number of patients with ctDNA positive and imaging confirmed recurrence or metastasis / number of all imaging confirmed recurrence or metastasis
Measured: Up to 60 months
Specificity of postoperative ctDNA in monitoring recurrence and metastasis
Number of patients with ctDNA negative and no recurrence and metastasis confirmed by imaging / number of patients with no recurrence and metastasis confirmed by imaging
Measured: Up to 60 months
Accuracy of postoperative ctDNA in monitoring recurrence and metastasis
True positive/ctDNA-positive samples
Measured: Up to 60 months
Secondary outcomes (2)
overall survival (OS)
Overall survival of included patients
Measured: From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months.
ctDNA clearance rate
The rate of ctDNA positive before chemotherapy that turns negative after adjuvant chemotherapy
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study startDec 2023 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion1 Apr 2026 (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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171321
- Sponsor's protocol ID
- [2023] R&R No. (107)
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 14 Dec 2023
- 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 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06171321
- Acronym / sponsor ID
- [2023] R&R No. (107)
- Conditions
- Biliary Tract Cancer
- Keywords
- S-1, circulating tumor DNA (ctDNA)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 14 Dec 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.
In recent years, circulating tumor DNA (ctDNA)had achieved encouraging results in monitoring recurrence and metastasis after surgery, and has potential clinical application value. The presence of ctDNA after surgery predicts very poor recurrence-free survival, whereas its absence predicts a low risk of recurrence. The benefit of adjuvant chemotherapy for ctDNA-positive patients is not well understood.
Detailed description
The results of the PRODIGE-12/ACCORD-18 study showed that, with a median follow-up of 47 months, the adjuvant chemotherapy arm did not lead to a significant improvement in recurrence-free survival (RFS) and overall survival (OS). Notably, the patients with gallbladder cancer experienced adjuvant chemotherapy significantly worse RFS and OS compared to those in the monitoring arm. ctDNA risk stratifies patients to guide adjuvant treatment decisions This study aimed to demonstrate that a escalation strategy of ctDNA guided adjuvant chemotherapy is superior to standard of care treatment as measured by 2 year disease free survival (DFS) in patients with stage II- III biliary tract cancers with minimal residual disease (MRD) (ctDNA positive).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients testing negative for ctDNA treated using standard of care treatment | No intervention | –Postoperative ctDNA-negative patients receive oral Teysuno (S-1) for adjuvant therapy。 |
| Group 2: Patients with a positive ctDNA test are treated with an escalation strategy | Experimental | Drug: S-1(Intravenous combined with oral)Postoperative ctDNA-positive patients receive intravenous combined oral Teysuno (S-1) for adjuvant therapy。 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1) Patients with pathologically confirmed BTCs according to the UICC/AJCC TNM staging system (8th edition 2017) for stage II-III tumours. Patients eligible for radical resection of BTCs. No synchronous or metastatic malignant tumour found in other organs other than the primary tumor.
- 2) Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 ~ 2.
- 3）With expected survival of more than 12 months. 4) Radical operation performed.
Key exclusion criteria (3 listed)
- 1) Patients with positive surgical margins and residual lesions after biliary tract tumor surgery.
- 2) Blood transfusion performed during operation or within 2 weeks before operation.
- 3) Have a history of other malignant tumors within 5 years.
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 |
|---|---|---|
| S-1(Intravenous combined with oral)Oral combined with intravenous S-1 for ctDNA-positive patients (escalating treatment strategy) | Drug | Group 2: Patients with a positive ctDNA test are treated with an escalation strategy |
Primary outcome
ctDNA guided adjuvant chemotherapy versus Translational sub study
Time frame: Up to 60 months
To demonstrate the superiority of an escalation strategy of ctDNA-guided adjuvant chemotherapy over standard-of-care treatment, 2-year disease-free survival (DFS) was measured as 2-year Disease-Free Survival (DFS) in high-risk stage II-III BTC patients with no evidence of minimal residual disease (ctDNA-negative).
Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis
Time frame: Up to 60 months
Number of patients with ctDNA positive and imaging confirmed recurrence or metastasis / number of all imaging confirmed recurrence or metastasis
Specificity of postoperative ctDNA in monitoring recurrence and metastasis
Time frame: Up to 60 months
Number of patients with ctDNA negative and no recurrence and metastasis confirmed by imaging / number of patients with no recurrence and metastasis confirmed by imaging
Accuracy of postoperative ctDNA in monitoring recurrence and metastasis
Time frame: Up to 60 months
True positive/ctDNA-positive samples
2 secondary outcomes
overall survival (OS)
Time frame: From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months.
ctDNA clearance rate
Time frame: Up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-1(Intravenous combined with oral) in people with Biliary Tract Cancer, run by Shanghai East 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 3 inclusion and 3 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 14 Dec 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.
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 Jinghan Wang, M.D. (+86-13795362134, wangjinghan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA guided adjuvant chemotherapy versus Translational sub study (time frame: Up to 60 months). The study lists 4 primary outcomes in all. 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 14 Dec 2023.