Biliary Tract Cancer (BTC)Phase 2NCT07893392
Phase II Study of Primary Tumor Resection and Selective Lymph Node Dissection Followed by RT for BTC With Lymph Node Metastases
A Phase 2 study testing Primary Tumor Resection and Selective Lymph Node Dissection, Postoperative Radiotherapy and Capecitabine or S-1 in people with Biliary Tract Cancer (BTC) and Surgery, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a multicenter, open-label, single-arm, prospective phase II clinical study. Eligible patients with lymph node-positive biliary tract cancer will undergo primary tumor resection with selective lymph node dissection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Tract Cancer (BTC), Surgery, Radiotherapy
- What is being tested?
- Primary Tumor Resection and Selective Lymph Node Dissection, Postoperative Radiotherapy and Capecitabine or S-1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2026to 31 Dec 2028
- 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
- Patients with suspected biliary tract carcinoma who are eligible for surgical exploration, with postoperative pathological confirmation of biliary tract adenocarcinoma;
- Age 18-80 years;
- Preoperative assessment indicating that the primary tumor is potentially amenable to R0/R1 resection;
- Preoperative evidence of lymph node metastases with at least one of the following features indicating that complete surgical resection or lymph node dissection may not be feasible:
- Local invasion of regional lymph nodes, such that complete surgical resection may not be feasible;
- Retroperitoneal lymph node metastases extending beyond the feasible surgical dissection field;
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- Whole-body PET/CT demonstrating metastatic lymph node involvement confined to a contiguous extended lymphatic field that can be encompassed within a single radiotherapy plan, with the involved lymph nodes extending from the lower paraesophageal lymph node region superiorly to the lymph nodes at the level of the abdominal aortic bifurcation inferiorly;
- No distant organ metastases, non-regional lymph node metastases, or intrahepatic metastatic lesions are allowed. Isolated right internal mammary lymph node or left supraclavicular lymph node involvement is permitted; however, these lesions will not be included in the initial radiotherapy field and may receive subsequent definitive local radiotherapy based on multidisciplinary evaluation and treatment response;
- Prior systemic therapy, including chemotherapy, targeted therapy, or immunotherapy, is permitted. Prior local treatment, including interventional therapy or radiofrequency ablation, is not permitted;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and a life expectancy of >3 months;
- Child-Pugh class A5 or A6;
- Liver function meeting the following criteria:
- ALT ≤2.5 × the upper limit of normal (ULN), with AST ≤6 × ULN when ALT ≤1.5 × ULN and AST ≤2.5 × ULN when ALT >1.5 × ULN but ≤2.5 × ULN, after excluding AST elevation due to myocardial infarction;
- Total bilirubin (TBIL) <60 μmol/L.
- No clinically significant abnormalities on electrocardiography, no significant cardiac insufficiency, and no contraindication to treatment with PD-1/PD-L1 inhibitors;
- Adequate renal function, defined as serum creatinine (CRE) and blood urea nitrogen (BUN) ≤2.5 × ULN;
- Adequate hematologic function, defined as hemoglobin (Hb) ≥80 g/L, absolute neutrophil count (ANC) ≥0.5 × 10⁹/L, and platelet count (PLT) ≥80 × 10⁹/L;
- Patients voluntarily participate in this clinical trial and sign an informed consent form.
Who cannot join
- Current participation in another interventional clinical trial involving an investigational drug or treatment;
- Previous abdominal radiotherapy or liver transplantation;
- Previous local treatment for the current malignancy, including interventional therapy or radiofrequency ablation;
- Known or suspected drug dependence, substance abuse, or alcohol abuse;
- Pregnancy or breastfeeding;
- Severe psychiatric or neurological disorders that may interfere with the ability to provide informed consent or with the reporting or assessment of adverse events;
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- Concurrent second primary malignancy or a history of another malignancy diagnosed within 3 years before enrollment, except for superficial skin cancers, localized low-grade malignancies, or carcinoma in situ that have been adequately treated and are not considered potentially life-threatening due to disease progression;
- Severe unhealed wounds, ulcers, or fractures;
- Biliary fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before enrollment;
- Unstable angina, myocardial infarction, coronary artery bypass grafting, congestive heart failure, or cerebrovascular events, including transient ischemic attack or pulmonary embolism, within 3 months before enrollment;
- Persistent arrhythmia of CTCAE grade ≥2, atrial fibrillation of any grade, or prolonged QTc interval (QTc >450 ms in males or >470 ms in females);
- Known HIV infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Bo Chen, MD, 0086-13240000876, chenboo@outlook.com
Bo Chen, MD
About this study
Official title: Phase II Study of Primary Tumor Resection and Selective Lymph Node Dissection Followed by Postoperative Radiotherapy for Biliary Tract Cancer With Lymph Node Metastases
This is a multicenter, open-label, single-arm, prospective phase II clinical study. Eligible patients with lymph node-positive biliary tract cancer will undergo primary tumor resection with selective lymph node dissection. During surgery, the regional and retroperitoneal lymph nodes will be explored, and lymph nodes that are technically amenable to surgical resection will be dissected. Metastatic lymph nodes that cannot be safely or completely resected because of local invasion or because of their location beyond the feasible surgical dissection field will not be surgically resected and will subsequently be treated with postoperative radiotherapy. Following surgery, patients will receive postoperative radiotherapy to the primary tumor bed and involved/regional lymph node areas. For patients who undergo R0 or R1 resection, concurrent chemoradiotherapy with capecitabine or S-1 will be administered for 2 cycles, followed by 6 cycles of adjuvant chemotherapy. For patients who undergo R2 resection, concurrent radiotherapy with capecitabine or S-1, with or without a PD-1/PD-L1 inhibitor, will be administered, followed by maintenance therapy with capecitabine or S-1, with or without a PD-1/PD-L1 inhibitor, until disease progression or unacceptable toxicity.
- Conditions
- Biliary Tract Cancer (BTC), Surgery, Radiotherapy
- Being tested
- Primary Tumor Resection and Selective Lymph Node Dissection, Postoperative Radiotherapy, Capecitabine or S-1
- Keywords
- Biliary Tract Cancer (BTC), Lymph Node Metastases, Primary Tumor Resection, Postoperative Radiotherapy
- Medical subject headings
- Biliary Tract Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Tumor Resection and Selective Lymph Node DissectionProcedure or surgery
Patients will undergo primary tumor resection with selective lymph node dissection. During surgery, regional and retroperitoneal lymph nodes will be explored, and lymph nodes that are technically amenable to surgical resection will be selectively dissected. Metastatic lymph nodes that cannot be safely or completely resected because of local invasion or because they extend beyond the feasible surgical dissection field will not be surgically resected and will subsequently be treated with postoperative radiotherapy.
Postoperative RadiotherapyRadiation
All patients will receive postoperative radiotherapy using intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT).
For patients undergoing R0/R1 resection, the high-risk tumor bed, including narrow-margin or lymph node-positive tumor beds, will receive 55-65 Gy in 20-25 fractions, while elective nodal regions will receive 40-45 Gy in 20-25 fractions. Radiotherapy to the primary tumor bed may be omitted when the surgical margin is considered adequate.
For patients undergoing R2 resection, the high-risk tumor bed will receive 55-65 Gy in 20-25 fractions, residual metastatic lymph nodes will receive 60-70 Gy in 20-25 fractions, and elective nodal regions will receive 40-45 Gy in 20-25 fractions. Radiotherapy to the primary tumor bed may be omitted when the surgical margin is considered adequate.
Capecitabine or S-1Drug
For patients undergoing R0/R1 resection, capecitabine or S-1 will be administered concurrently with radiotherapy for 2 cycles, followed by 6 cycles of adjuvant chemotherapy. Capecitabine will be administered at 1,600 mg/m² on Days 1-14 every 21 days during radiotherapy and 2,000 mg/m² on Days 1-14 every 21 days for 6 subsequent cycles. For patients intolerant to capecitabine, S-1 will be substituted: concurrent S-1 40-50 mg twice daily on Days 1-28, every 42 days for 1 cycle, followed by maintenance S-1 40-60 mg twice daily on Days 1-28, every 42 days for 3 cycles.
For patients undergoing R2 resection, capecitabine or S-1, with or without a PD-1/PD-L1 inhibitor, will be administered concurrently with radiotherapy, followed by maintenance treatment with the same regimen until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Primary Tumor Resection and Selective Lymph Node Dissection Followed by RT | Experimental | Not described Receives: Procedure: Primary Tumor Resection and Selective Lymph Node Dissection; Radiation: Postoperative Radiotherapy; Drug: Capecitabine or S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Overall Survival
Median Overall Survival (mOS) is defined as the median of Overall Survival (OS). OS is defined as the time from the date of surgery to death from any cause
Measured: 24 months
Secondary outcomes (5)
Median Progression-free Survival
Median Progression-free Survival (mPFS) is defined as the median of Progression-free Survival (PFS). PFS is defined as the time from the date of surgery until tumor progression or death from any cause.
Measured: 24 months
R0/R1 resection rate
R0/R1 Resection Rate is defined as the percentage of patients who achieve R0 or R1 resection among all patients undergoing surgery
Measured: At the completion of surgery
Completion Rate of Treatment Protocol
Completion Rate of the Surgery Plus Radiotherapy Treatment Protocol is defined as the percentage of patients who complete both planned surgery and postoperative radiotherapy according to the study protocol.
Measured: Up to 6 months after surgery
Objective Response Rate (ORR) in Patients Undergoing R2 Resection
Objective Response Rate (ORR) After Postoperative Radiotherapy in Patients Undergoing R2 Resection is defined as the percentage of patients with R2 resection who achieve complete response (CR) or partial response (PR) as their best overall response within 3 months after completion of postoperative radiotherapy, according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and RECIST 1.1.
Measured: Assessment in 1 to 3 months after radiotherapy
Incidence of Grade ≥3 Adverse Events Following Postoperative Radiotherapy
Adverse events are assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The outcome is defined as the proportion of patients who experience grade ≥3 adverse events following postoperative radiotherapy.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start8 Oct 2026
- Primary completion8 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract Cancer (BTC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BO CHEN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893392
- Sponsor's protocol ID
- LX202609003
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Primary Tumor Resection and Selective Lymph Node Dissection Followed by Postoperative Radiotherapy for Biliary Tract Cancer With Lymph Node Metastases
- ClinicalTrials.gov ID
- NCT07893392
- Acronym / sponsor ID
- LX202609003
- Conditions
- Biliary Tract Cancer (BTC), Surgery, Radiotherapy
- Keywords
- Biliary Tract Cancer (BTC), Lymph Node Metastases, Primary Tumor Resection, Postoperative Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- 8 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Oct 2026 (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 is a multicenter, open-label, single-arm, prospective phase II clinical study. Eligible patients with lymph node-positive biliary tract cancer will undergo primary tumor resection with selective lymph node dissection. During surgery, the regional and retroperitoneal lymph nodes will be explored, and lymph nodes that are technically amenable to surgical resection will be dissected. Metastatic lymph nodes that cannot be safely or completely resected because of local invasion or because of their location beyond the feasible surgical dissection field will not be surgically resected and will subsequently be treated with postoperative radiotherapy. Following surgery, patients will receive postoperative radiotherapy to the primary tumor bed and involved/regional lymph node areas. For patients who undergo R0 or R1 resection, concurrent chemoradiotherapy with capecitabine or S-1 will be administered for 2 cycles, followed by 6 cycles of adjuvant chemotherapy. For patients who undergo R2 resection, concurrent radiotherapy with capecitabine or S-1, with or without a PD-1/PD-L1 inhibitor, will be administered, followed by maintenance therapy with capecitabine or S-1, with or without a PD-1/PD-L1 inhibitor, until disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Tumor Resection and Selective Lymph Node Dissection Followed by RT | Experimental | Procedure: Primary Tumor Resection and Selective Lymph Node Dissection, Radiation: Postoperative Radiotherapy, Drug: Capecitabine or S-1 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients with suspected biliary tract carcinoma who are eligible for surgical exploration, with postoperative pathological confirmation of biliary tract adenocarcinoma;
- Age 18-80 years;
- Preoperative assessment indicating that the primary tumor is potentially amenable to R0/R1 resection;
- Preoperative evidence of lymph node metastases with at least one of the following features indicating that complete surgical resection or lymph node dissection may not be feasible:
- Whole-body PET/CT demonstrating metastatic lymph node involvement confined to a contiguous extended lymphatic field that can be encompassed within a single radiotherapy plan, with the involved lymph nodes extending from the lower paraesophageal lymph node region superiorly to the lymph nodes at the level of the abdominal aortic bifurcation inferiorly;
Key exclusion criteria (12 listed)
- Current participation in another interventional clinical trial involving an investigational drug or treatment;
- Previous abdominal radiotherapy or liver transplantation;
- Previous local treatment for the current malignancy, including interventional therapy or radiofrequency ablation;
- Known or suspected drug dependence, substance abuse, or alcohol abuse;
- Pregnancy or breastfeeding;
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 |
|---|---|---|
| Primary Tumor Resection and Selective Lymph Node DissectionPatients will undergo primary tumor resection with selective lymph node dissection. During surgery, regional and retroperitoneal lymph nodes will be explored, and lymph nodes that are technically amenable to surgical resection will be selectively dissected. Metastatic lymph nodes that cannot be safely or completely resected because of local invasion or because they extend beyond the feasible surgical dissection field will not be surgically resected and will subsequently be treated with postoperative radiotherapy. | Procedure or surgery | Primary Tumor Resection and Selective Lymph Node Dissection Followed by RT |
| Postoperative RadiotherapyAll patients will receive postoperative radiotherapy using intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT). For patients undergoing R0/R1 resection, the high-risk tumor bed, including narrow-margin or lymph node-positive tumor beds, will receive 55-65 Gy in 20-25 fractions, while elective nodal regions will receive 40-45 Gy in 20-25 fractions. Radiotherapy to the primary tumor bed may be omitted when the surgical margin is considered adequate. For patients undergoing R2 resection, the high-risk tumor bed will receive 55-65 Gy in 20-25 fractions, residual metastatic lymph nodes will receive 60-70 Gy in 20-25 fractions, and elective nodal regions will receive 40-45 Gy in 20-25 fractions. Radiotherapy to the primary tumor bed may be omitted when the surgical margin is considered adequate. | Radiation | Primary Tumor Resection and Selective Lymph Node Dissection Followed by RT |
| Capecitabine or S-1For patients undergoing R0/R1 resection, capecitabine or S-1 will be administered concurrently with radiotherapy for 2 cycles, followed by 6 cycles of adjuvant chemotherapy. Capecitabine will be administered at 1,600 mg/m² on Days 1-14 every 21 days during radiotherapy and 2,000 mg/m² on Days 1-14 every 21 days for 6 subsequent cycles. For patients intolerant to capecitabine, S-1 will be substituted: concurrent S-1 40-50 mg twice daily on Days 1-28, every 42 days for 1 cycle, followed by maintenance S-1 40-60 mg twice daily on Days 1-28, every 42 days for 3 cycles. For patients undergoing R2 resection, capecitabine or S-1, with or without a PD-1/PD-L1 inhibitor, will be administered concurrently with radiotherapy, followed by maintenance treatment with the same regimen until disease progression or unacceptable toxicity. | Drug | Primary Tumor Resection and Selective Lymph Node Dissection Followed by RT |
Primary outcome
Median Overall Survival
Time frame: 24 months
Median Overall Survival (mOS) is defined as the median of Overall Survival (OS). OS is defined as the time from the date of surgery to death from any cause
5 secondary outcomes
Median Progression-free Survival
Time frame: 24 months
R0/R1 resection rate
Time frame: At the completion of surgery
Completion Rate of Treatment Protocol
Time frame: Up to 6 months after surgery
Objective Response Rate (ORR) in Patients Undergoing R2 Resection
Time frame: Assessment in 1 to 3 months after radiotherapy
Incidence of Grade ≥3 Adverse Events Following Postoperative Radiotherapy
Time frame: 24 months
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Primary Tumor Resection and Selective Lymph Node Dissection, Postoperative Radiotherapy and Capecitabine or S-1 in people with Biliary Tract Cancer (BTC) and Surgery, 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 18 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
Contact Bo Chen, MD (0086-13240000876, chenboo@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Overall Survival (time frame: 24 months). 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 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.