Extrahepatic Cholangiocarcinoma and Gallbladder CarcinomaPhase 2NCT07636824
Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study
A Phase 2 study testing Postoperative radiotherapy and Capecitabine or S-1 in people with Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma, 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 trial. The study enrolls patients with extrahepatic cholangiocarcinoma or gallbladder carcinoma who have undergone curative resection and harbor high-risk recurrence factors, including: 1) narrow resection margin (including R1 resection); 2)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
- What is being tested?
- Postoperative radiotherapy and Capecitabine or S-1
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2026to 30 May 2029
- Phase
- Phase 2
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
- Aged 18-80 years
- Underwent curative resection for newly diagnosed disease, with postoperative pathology confirming extrahepatic cholangiocarcinoma or gallbladder adenocarcinoma
- Postoperative pathology with ≥1 high-risk factor for recurrence
- Narrow resection margin (<1 cm), including R1 resection
- Positive circumferential resection margin
- T stage ≥ T3-4
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- Positive regional lymph nodes
- Postoperative liver function: Child-Pugh grade A5-B7
- No recurrence or metastasis before postoperative radiotherapy
- ECOG performance status 0-2
- Expected survival >3 months
- Routine blood tests: Neutrophils ≥1.0×10⁹/L, hemoglobin ≥80 g/L, platelets ≥100×10⁹/L
- Liver function: Total bilirubin <1.5×upper limit of normal (ULN), plus one of the following:
- ALT and AST ≤2.5×ULN
- ALT ≤1.5×ULN and AST ≤6×ULN (excluding AST elevation due to myocardial infarction)
- Renal function: Creatinine and blood urea nitrogen ≤2.5×ULN
- Voluntary participation and signed informed consent
Who cannot join
- History of other malignant tumors (except papillary thyroid carcinoma, basal cell carcinoma of the skin, and cervical carcinoma in situ)
- Severe comorbidities (e.g., myocardial infarction, arrhythmia, psychiatric disorders)
- Prior abdominal radiotherapy
- Post-organ transplantation
- Symptomatic moderate-severe ascites within 4 months postoperatively
- ≥4 months since surgery
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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
Bo Chen, MD, 00861324000876, chenboo@outlook.com
About this study
This is a multicenter, open-label, single-arm, prospective Phase II clinical trial. The study enrolls patients with extrahepatic cholangiocarcinoma or gallbladder carcinoma who have undergone curative resection and harbor high-risk recurrence factors, including: 1) narrow resection margin (including R1 resection); 2) positive circumferential resection margin; 3) T stage ≥ T3-4; 4）positive regional lymph nodes. All patients will receive postoperative concurrent chemoradiotherapy (CCRT) with intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). The high-risk volumes of the primary tumor bed and metastatic lymph node beds will be irradiated to 48-60 Gy in 20-25 fractions. Retroperitoneal and intra-abdominal lymph nodes will receive 50-57.5 Gy in 20-25 fractions, and lymphatic drainage regions will be treated to 40-45 Gy in 20-25 fractions. During radiotherapy, concurrent oral capecitabine will be administered at a dose of 1,600 mg/m² on Days 1-14, every 21 days for 2 cycles. Following the completion of radiotherapy, maintenance oral capecitabine will be continued at 2,000 mg/m² on Days 1-14, every 21 days for 6 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.
The primary study endpoint is the 2-year recurrence-free survival (RFS) rate. Secondary study endpoints include the 2-year overall survival (OS) rate, locoregional control rate, and incidence of grade ≥3 adverse events.
A total of 92 patients are planned for enrollment in this trial.
- Being tested
- Postoperative radiotherapy, Capecitabine or S-1
- Medical subject headings
- Cholangiocarcinoma, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative radiotherapyRadiation
All patients will receive postoperative concurrent chemoradiotherapy with IMRT or VMAT. The high-risk volumes of the primary tumor bed and metastatic lymph node beds will be irradiated to 48-60 Gy in 20-25 fractions. Retroperitoneal and intra-abdominal lymph nodes will receive 50-57.5 Gy in 20-25 fractions, and lymphatic drainage regions will be treated to 40-45 Gy in 20-25 fractions.
Capecitabine or S-1Drug
During radiotherapy, concurrent oral capecitabine will be administered at a dose of 1,600 mg/m² on Days 1-14, every 21 days for 2 cycles. Following the completion of radiotherapy, maintenance oral capecitabine will be continued at 2,000 mg/m² on Days 1-14, every 21 days for 6 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.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Concurrent Chemoradiotherapy Group | Experimental | Not described Receives: 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.
2-year recurrence-free survival (RFS) rate
Measured: From completion of radiotherapy until 2 years after radiotherapy
Secondary outcomes (3)
2-year overall survival (OS) rate
Measured: From completion of radiotherapy until 2 years after radiotherapy
Locoregional control rate
Measured: From completion of radiotherapy until 2 years after radiotherapy
Incidence of grade ≥3 treatment-related adverse events
Measured: From initiation of radiotherapy until 3 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start16 Jun 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Extrahepatic Cholangiocarcinoma and Gallbladder CarcinomaStudies 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
- 92 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
- NCT07636824
- Sponsor's protocol ID
- NCC6244
- Status last verified
- Jun 2026
- First submitted
- 31 May 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng Q, Lv B, Chen Y, Hsu S, Zhang Y, Wang S, Liu H, Suo T, Zeng Z, Du S. Adjuvant Chemoradiation Therapy Versus Chemotherapy Alone After Resection of Gallbladder Carcinoma: A Real-World, Inverse Probability of Treatment Weighting-Based Cohort Study. Int J Radiat Oncol Biol Phys. 2026 Feb 1;124(2):415-427. doi: 10.1016/j.ijrobp.2025.09.023. Epub 2025 Sep 16.
PubMed 40967375Gholami S, Colby S, Horowitz DP, Guthrie KA, Ben-Josef E, El-Khoueiry AB, Blanke CD, Philip PA, Kachnic LA, Ahmad SA, Rocha FG. Adjuvant Chemoradiation in Patients with Lymph Node-Positive Biliary Tract Cancers: Secondary Analysis of a Single-Arm Clinical Trial (SWOG 0809). Ann Surg Oncol. 2023 Mar;30(3):1354-1363. doi: 10.1245/s10434-022-12863-9. Epub 2023 Jan 9.
PubMed 36622529Ben-Josef E, Guthrie KA, El-Khoueiry AB, Corless CL, Zalupski MM, Lowy AM, Thomas CR Jr, Alberts SR, Dawson LA, Micetich KC, Thomas MB, Siegel AB, Blanke CD. SWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma. J Clin Oncol. 2015 Aug 20;33(24):2617-22. doi: 10.1200/JCO.2014.60.2219. Epub 2015 May 11.
PubMed 25964250Horgan AM, Amir E, Walter T, Knox JJ. Adjuvant therapy in the treatment of biliary tract cancer: a systematic review and meta-analysis. J Clin Oncol. 2012 Jun 1;30(16):1934-40. doi: 10.1200/JCO.2011.40.5381. Epub 2012 Apr 23.
PubMed 22529261Kamarajah SK, Bednar F, Cho CS, Nathan H. Survival benefit with adjuvant radiotherapy after resection of distal cholangiocarcinoma: A propensity-matched National Cancer Database analysis. Cancer. 2021 Apr 15;127(8):1266-1274. doi: 10.1002/cncr.33356. Epub 2020 Dec 15.
PubMed 33320344Ren B, Guo Q, Yang Y, Liu L, Wei S, Chen W, Tian Y. A meta-analysis of the efficacy of postoperative adjuvant radiotherapy versus no radiotherapy for extrahepatic cholangiocarcinoma and gallbladder carcinoma. Radiat Oncol. 2020 Jan 15;15(1):15. doi: 10.1186/s13014-020-1459-x.
PubMed 31941520Jeong H, Kim KP, Jeong JH, Hwang DW, Lee JH, Kim KH, Moon DB, Lee MA, Park SJ, Chon HJ, Park JH, Lee JS, Ryoo BY, Yoo C. Adjuvant gemcitabine plus cisplatin versus capecitabine in node-positive extrahepatic cholangiocarcinoma: the STAMP randomized trial. Hepatology. 2023 May 1;77(5):1540-1549. doi: 10.1097/HEP.0000000000000046. Epub 2023 Jan 3.
PubMed 37070950Nakachi K, Ikeda M, Konishi M, Nomura S, Katayama H, Kataoka T, Todaka A, Yanagimoto H, Morinaga S, Kobayashi S, Shimada K, Takahashi Y, Nakagohri T, Gotoh K, Kamata K, Shimizu Y, Ueno M, Ishii H, Okusaka T, Furuse J; Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG). Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet. 2023 Jan 21;401(10372):195-203. doi: 10.1016/S0140-6736(22)02038-4.
PubMed 36681415Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. doi: 10.1016/S1470-2045(18)30915-X. Epub 2019 Mar 25.
PubMed 30922733Tran Cao HS, Zhang Q, Sada YH, Chai C, Curley SA, Massarweh NN. The role of surgery and adjuvant therapy in lymph node-positive cancers of the gallbladder and intrahepatic bile ducts. Cancer. 2018 Jan 1;124(1):74-83. doi: 10.1002/cncr.30968. Epub 2017 Aug 25.
PubMed 28841223Wheless M, Agarwal R, Goff L, Lockney N, Padmanabhan C, Heumann T. Current Standards, Multidisciplinary Approaches, and Future Directions in the Management of Extrahepatic Cholangiocarcinoma. Curr Treat Options Oncol. 2024 Jan;25(1):127-160. doi: 10.1007/s11864-023-01153-5. Epub 2024 Jan 5.
PubMed 38177560Bridgewater JA, Goodman KA, Kalyan A, Mulcahy MF. Biliary Tract Cancer: Epidemiology, Radiotherapy, and Molecular Profiling. Am Soc Clin Oncol Educ Book. 2016;35:e194-203. doi: 10.1200/EDBK_160831.
PubMed 27249723Valle JW, Borbath I, Khan SA, Huguet F, Gruenberger T, Arnold D; ESMO Guidelines Committee. Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Sep;27(suppl 5):v28-v37. doi: 10.1093/annonc/mdw324. No abstract available.
PubMed 27664259Saha SK, Zhu AX, Fuchs CS, Brooks GA. Forty-Year Trends in Cholangiocarcinoma Incidence in the U.S.: Intrahepatic Disease on the Rise. Oncologist. 2016 May;21(5):594-9. doi: 10.1634/theoncologist.2015-0446. Epub 2016 Mar 21.
PubMed 27000463Mirallas O, Lopez-Valbuena D, Garcia-Illescas D, Fabregat-Franco C, Verdaguer H, Tabernero J, Macarulla T. Advances in the systemic treatment of therapeutic approaches in biliary tract cancer. ESMO Open. 2022 Jun;7(3):100503. doi: 10.1016/j.esmoop.2022.100503. Epub 2022 Jun 10.
PubMed 35696747