CholangiocarcinomaPhase 2TisGCS for BTCNCT06903273
Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Resectable High-risk Cholangiocarcinoma
A Phase 2 study testing Tislelizumab in people with Cholangiocarcinoma and Biliary Tract Cancer (BTC), run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
To investigate the efficacy and tolerability of neoadjuvant tislelizumab, gemcitabine, cisplatin and S-1 (TisGCS) in patients with resectable high-risk iCCA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Biliary Tract Cancer (BTC)
- What is being tested?
- Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2025to 1 Jul 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet the criteria of either (A) or (B), plus 1. to 6. (A) High-risk group (HR) Subjects have histologically-confirmed and potentially resectable intrahepatic cholangiocarcinoma, according to the definition of American Joint Cancer Committee staging system, 8th edition (AJCC 8th).
- Plus at least one of the following high-risk features,
- Solitary tumor with a maximal diameter ≥5 cm in the absence of vascular invasion.
- ≥T1b disease which is resectable.
- Multifocal tumors or single tumor with satellite nodules at the same anatomic liver lobe which is/are resectable.
- Tumor(s) with macroscopic intrahepatic vascular invasion but is/are potentially resectable.
Show all 15Show fewer
- Image or histological evidence of hilar or portal lymph node involvement (N1).
- Initial serum cancer antigen-199 (CA199) ≥200 U/mL.
- Very early recurrence group (VER) Subjects with previously resected cholangiocarcinoma under a curative intent and have an early recurrent disease (≤6 months post curative surgery) confined to the liver, with/without antecedent adjuvant local or systemic therapies, and can be re-resected under a curative intent.
- Subjects present with at least one measurable lesion which can be accurately assessed by conventional techniques at least 1.0 cm by computed tomography (CT) or magnetic resonance imaging (MRI).
- Subjects are above 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤1, have a life expectancy \>3 months, have surgically resectable disease and are physically competent and willing to receive a curative operation following the study protocol
- Subjects have adequate organ functions, including bone marrow reserve with a leukocyte count ≥3,000 /µL and platelet count ≥50,000 /µL, hepatic reserve with a serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin ≤3 times of upper normal testing limits (biliary drainage is permitted), renal reserve with a creatinine clearance ≥60 mL/min and cardiac reserve with a New York Heart Association (NYHA) functional classification I at baseline.
- Subjects have or agree to establish a vascular access that permits intravenous administration of medications and are capable of ingesting capsules per oral.
- Subjects with reproductive potentials are willing to accept contraceptive measures during the trial.
- Subjects are functionally and cognitively capable to be informed of the trial contents and objectives (including obtaining blood and tumor tissue for the trial investigation), and agree to sign the written consent for enrollment.
Who cannot join
- Subjects have metastatic (M1) disease, recurrent cholangiocarcinoma which cannot be resected, recurrent cholangiocarcinoma which can be re-resected but occurs \>6 months post previous surgery, or any other primary malignancies in which the subjects have been in disease-free status less than 2 years, excluding carcinoma in situ or resectable skin cancer.
- Subjects have received a systemic therapy with either chemotherapeutics or immune checkpoint inhibitors, a major abdominal surgery or radiotherapy within 4 weeks before the trial enrollment.
- Subjects are known to be severely allergic to any of the studied therapeutics.
- Subjects have underlying chronic illnesses, including cardiopulmonary diseases, ischemic heart disease, inflammatory bowel disease, poorly-controlled diabetes mellitus, liver cirrhosis and/or debilitating autoimmune diseases or conditions.
- 5 Subjects are receiving or have received a systemic administration of an equivalent dose of daily 10 mg prednisone or above for ≥14 days in whatever indications within 4 weeks before the trial enrollment, or immunosuppressives for ≥7 days within 4 weeks before the trial enrollment.
- 6. Subjects have active bacterial, viral, fungal or mycobacterial infections that require systemic therapy, including active infection with human immunodeficiency virus (HIV), hepatitis B or C virus (HBV or HCV).
- 7. Subjects are planning to conceive or already in pregnancy or breastfeeding. 8. Subjects are currently participating in any other clinical trials or studies which potentially interfere the protocol commencement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Trial Center, National Cheng Kung University Hospital contact
Taiwan1 site
National Cheng Kung University Hospital
Tainan, 70403
Chih Chieh Yen, MD., PhD., 886-6-2353535 ext. 6552, jack7481@gmail.com
About this study
Official title: Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Patients with Resectable High-risk Intrahepatic Cholangiocarcinoma
To investigate the efficacy and tolerability of neoadjuvant tislelizumab, gemcitabine, cisplatin and S-1 (TisGCS) in patients with resectable high-risk iCCA.
Read the detailed description
Patients with cholangiocarcinoma have limited therapeutic options and a poor prognosis. Margin-free resection is the only curative treatment to treat intrahepatic cholangiocarcinoma (iCCA). However, patients with resectable disease still suffer from high recurrence or progression. Both immune checkpoint inhibitors and chemotherapy have shed light on treating patients with iCCA. Nevertheless, the role of neoadjuvant chemo-immunotherapy has not been established in patients with resectable iCCA harboring a high risk for recurrence. The aim of the trial is to investigate the efficacy and tolerability of neoadjuvant tislelizumab, gemcitabine, cisplatin and S-1 (Tis-GCS) in patients with resectable high-risk iCCA. The primary outcome is R0 resection rate. The secondary outcome includes objective response rate, event-free survival, overall survival, protocol completion rate and adverse events. The study is an open-label, single-arm and multi-center phase II investigator-initiated trial with Simon two-stage design. Subjects with resectable iCCA harboring a high risk for recurrence or those suffer from very early recurrent disease who are eligible for a curative resection are included. A total of 35 subjects are expected with a minimal sample size of 14 when the R0 resection rate is of the lower threshold. Tis-GCS (14 days as a cycle) 3 cycles every 2 weeks will be administered and followed by surgery. Tislelizumab 200 mg fixed-dose, gemcitabine 800 mg/m2 and cisplatin 25 mg/m2 is given intravenously on day 1. S-1 (35 mg/m2) is given twice daily per oral on day 1 to 7. The study will prove the feasibility and efficacy of neoadjuvant chemo-immunotherapy in resectable high-risk iCCA. The results may provide critical fundamentals into future phase III clinical trials.
- Conditions
- Cholangiocarcinoma, Biliary Tract Cancer (BTC)
- Being tested
- Tislelizumab
- Keywords
- cholangiocarcinoma, biliary tract cancer, neoadjuvant, gemcitabine, S-1, preoperative, resectable, tislelizumab, cisplatin
- Medical subject headings
- Cholangiocarcinoma, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called gemcitabine, cisplatin, S-1
Tislelizumab plus chemotherapy (14 days as one cycle) 3 cycles every 2 weeks as neoadjuvant therapy and followed by a curative surgery.
Tislelizumab 200 mg fixed-dose IVD on day 1. Gemcitabine 800 mg/m2 on day 1 with a fixed-infusion rate of 80 mins. Cisplatin 25 mg/m2 on day 1. S-1 70 mg/m2 daily as a BID dosing per oral on day 1 to 7. (daily total dose determined by body surface area (BSA): <1.25 m2, 80 mg; 1.25-1.50 m2, 100 mg; ≥1.50 m2, 120 mg)
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab-Gemcitabine/Cisplatin/S-1 | Experimental | neoadjuvant tislelizumab/gemcitabine/cisplatin/S-1 Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Margin-free resection (R0) rate: (Number of patients with surgical results achieving an uninvolved margin under microscopic and macroscopic inspection) / (Number of patients receiving a surgery) x 100%
Measured: From enrollment to surgical resection at 2 weeks
Secondary outcomes (4)
Objective response rate
Patients who achieve a complete or partial response as defined by revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: From enrollment to the end of neoadjuvant therapy at 2 weeks
Overall survival
The time interval from enrollment to death by any causes
Measured: From the date of enrollment until the date of death from any cause
Event-free survival
The time interval from enrollment to an event, defined as disease progression, recurrence, withdrawal from trial treatment, initiation of subsequent anticancer treatment or death by any cause, in whichever happens first.
Measured: From the date of enrollment until the date of any predefined event which happens first
Disease control rate
Patients who achieve a complete response, partial response or stable disease, as defined by revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: From enrollment to the end of neoadjuvant therapy at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University 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
- Not applicable
- Intervention model
- Single group
- Model description
- Simon two-staged design
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Veterans General Hospital., Chi Mei Medical Hospital
- Responsible party
- Principal investigator, Chih Chieh, Yen, National Cheng-Kung University Hospital
- Investigators
- Chia Jui Yen, MD., PhD, Principal investigator, Department on Oncology, National Cheng Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903273
- Sponsor's protocol ID
- NCKUH-BTC-01
- Acronym
- TisGCS for BTC
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol
Publications
Maithel SK, Keilson JM, Cao HST, Rupji M, Mahipal A, Lin BS, Javle MM, Cleary SP, Akce M, Switchenko JM, Rocha FG. NEO-GAP: A Single-Arm, Phase II Feasibility Trial of Neoadjuvant Gemcitabine, Cisplatin, and Nab-Paclitaxel for Resectable, High-Risk Intrahepatic Cholangiocarcinoma. Ann Surg Oncol. 2023 Oct;30(11):6558-6566. doi: 10.1245/s10434-023-13809-5. Epub 2023 Jun 27.
PubMed 37368098Oh DY, Ruth He A, Qin S, Chen LT, Okusaka T, Vogel A, Kim JW, Suksombooncharoen T, Ah Lee M, Kitano M, Burris H, Bouattour M, Tanasanvimon S, McNamara MG, Zaucha R, Avallone A, Tan B, Cundom J, Lee CK, Takahashi H, Ikeda M, Chen JS, Wang J, Makowsky M, Rokutanda N, He P, Kurland JF, Cohen G, Valle JW. Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer. NEJM Evid. 2022 Aug;1(8):EVIDoa2200015. doi: 10.1056/EVIDoa2200015. Epub 2022 Jun 1.
PubMed 38319896Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16.
PubMed 37075781Ioka T, Kanai M, Kobayashi S, Sakai D, Eguchi H, Baba H, Seo S, Taketomi A, Takayama T, Yamaue H, Takahashi M, Sho M, Kamei K, Fujimoto J, Toyoda M, Shimizu J, Goto T, Shindo Y, Yoshimura K, Hatano E, Nagano H; Kansai Hepatobiliary Oncology Group (KHBO). Randomized phase III study of gemcitabine, cisplatin plus S-1 versus gemcitabine, cisplatin for advanced biliary tract cancer (KHBO1401- MITSUBA). J Hepatobiliary Pancreat Sci. 2023 Jan;30(1):102-110. doi: 10.1002/jhbp.1219. Epub 2022 Aug 9.
PubMed 35900311
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Patients with Resectable High-risk Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT06903273
- Acronym / sponsor ID
- TisGCS for BTC / NCKUH-BTC-01
- Conditions
- Cholangiocarcinoma, Biliary Tract Cancer (BTC)
- Keywords
- cholangiocarcinoma, biliary tract cancer, neoadjuvant, gemcitabine, S-1, preoperative, resectable, tislelizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Kaohsiung Veterans General Hospital., Chi Mei Medical Hospital
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 30 Mar 2025 (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.
To investigate the efficacy and tolerability of neoadjuvant tislelizumab, gemcitabine, cisplatin and S-1 (TisGCS) in patients with resectable high-risk iCCA.
Detailed description
Patients with cholangiocarcinoma have limited therapeutic options and a poor prognosis. Margin-free resection is the only curative treatment to treat intrahepatic cholangiocarcinoma (iCCA). However, patients with resectable disease still suffer from high recurrence or progression. Both immune checkpoint inhibitors and chemotherapy have shed light on treating patients with iCCA. Nevertheless, the role of neoadjuvant chemo-immunotherapy has not been established in patients with resectable iCCA harboring a high risk for recurrence. The aim of the trial is to investigate the efficacy and tolerability of neoadjuvant tislelizumab, gemcitabine, cisplatin and S-1 (Tis-GCS) in patients with resectable high-risk iCCA. The primary outcome is R0 resection rate. The secondary outcome includes objective response rate, event-free survival, overall survival, protocol completion rate and adverse events. The study is an open-label, single-arm and multi-center phase II investigator-initiated trial with Simon two-stage design. Subjects with resectable iCCA harboring a high risk for recurrence or those suffer from very early recurrent disease who are eligible for a curative resection are included. A total of 35 subjects are expected with a minimal sample size of 14 when the R0 resection rate is of the lower threshold. Tis-GCS (14 days as a cycle) 3 cycles every 2 weeks will be administered and followed by surgery. Tislelizumab 200 mg fixed-dose, gemcitabine 800 mg/m2 and cisplatin 25 mg/m2 is given intravenously on day 1. S-1 (35 mg/m2) is given twice daily per oral on day 1 to 7. The study will prove the feasibility and efficacy of neoadjuvant chemo-immunotherapy in resectable high-risk iCCA. The results may provide critical fundamentals into future phase III clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Simon two-staged design
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab-Gemcitabine/Cisplatin/S-1 | Experimental | Drug: Tislelizumabneoadjuvant tislelizumab/gemcitabine/cisplatin/S-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects must meet the criteria of either (A) or (B), plus 1. to 6. (A) High-risk group (HR) Subjects have histologically-confirmed and potentially resectable intrahepatic cholangiocarcinoma, according to the definition of American Joint Cancer Committee staging system, 8th edition (AJCC 8th).
- Plus at least one of the following high-risk features,
- Solitary tumor with a maximal diameter ≥5 cm in the absence of vascular invasion.
- ≥T1b disease which is resectable.
- Multifocal tumors or single tumor with satellite nodules at the same anatomic liver lobe which is/are resectable.
Key exclusion criteria (7 listed)
- 5 Subjects are receiving or have received a systemic administration of an equivalent dose of daily 10 mg prednisone or above for ≥14 days in whatever indications within 4 weeks before the trial enrollment, or immunosuppressives for ≥7 days within 4 weeks before the trial enrollment.
- 6. Subjects have active bacterial, viral, fungal or mycobacterial infections that require systemic therapy, including active infection with human immunodeficiency virus (HIV), hepatitis B or C virus (HBV or HCV).
- 7. Subjects are planning to conceive or already in pregnancy or breastfeeding. 8. Subjects are currently participating in any other clinical trials or studies which potentially interfere the protocol commencement.
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 |
|---|---|---|
| TislelizumabAlso: gemcitabine, cisplatin, S-1Tislelizumab plus chemotherapy (14 days as one cycle) 3 cycles every 2 weeks as neoadjuvant therapy and followed by a curative surgery. Tislelizumab 200 mg fixed-dose IVD on day 1. Gemcitabine 800 mg/m2 on day 1 with a fixed-infusion rate of 80 mins. Cisplatin 25 mg/m2 on day 1. S-1 70 mg/m2 daily as a BID dosing per oral on day 1 to 7. (daily total dose determined by body surface area (BSA): <1.25 m2, 80 mg; 1.25-1.50 m2, 100 mg; ≥1.50 m2, 120 mg) | Drug | Tislelizumab-Gemcitabine/Cisplatin/S-1 |
Primary outcome
R0 resection rate
Time frame: From enrollment to surgical resection at 2 weeks
Margin-free resection (R0) rate: (Number of patients with surgical results achieving an uninvolved margin under microscopic and macroscopic inspection) / (Number of patients receiving a surgery) x 100%
4 secondary outcomes
Objective response rate
Time frame: From enrollment to the end of neoadjuvant therapy at 2 weeks
Overall survival
Time frame: From the date of enrollment until the date of death from any cause
Event-free survival
Time frame: From the date of enrollment until the date of any predefined event which happens first
Disease control rate
Time frame: From enrollment to the end of neoadjuvant therapy at 2 weeks
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 30 Mar 2025.
- Background: PubMed 37368098Maithel SK, Keilson JM, Cao HST, Rupji M, Mahipal A, Lin BS, Javle MM, Cleary SP, Akce M, Switchenko JM, Rocha FG. NEO-GAP: A Single-Arm, Phase II Feasibility Trial of Neoadjuvant Gemcitabine, Cisplatin, and Nab-Paclitaxel for Resectable, High-Risk Intrahepatic Cholangiocarcinoma. Ann Surg Oncol. 2023 Oct;30(11):6558-6566. doi: 10.1245/s10434-023-13809-5. Epub 2023 Jun 27.
- Background: PubMed 38319896Oh DY, Ruth He A, Qin S, Chen LT, Okusaka T, Vogel A, Kim JW, Suksombooncharoen T, Ah Lee M, Kitano M, Burris H, Bouattour M, Tanasanvimon S, McNamara MG, Zaucha R, Avallone A, Tan B, Cundom J, Lee CK, Takahashi H, Ikeda M, Chen JS, Wang J, Makowsky M, Rokutanda N, He P, Kurland JF, Cohen G, Valle JW. Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer. NEJM Evid. 2022 Aug;1(8):EVIDoa2200015. doi: 10.1056/EVIDoa2200015. Epub 2022 Jun 1.
- Background: PubMed 37075781Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16.
- Background: PubMed 35900311Ioka T, Kanai M, Kobayashi S, Sakai D, Eguchi H, Baba H, Seo S, Taketomi A, Takayama T, Yamaue H, Takahashi M, Sho M, Kamei K, Fujimoto J, Toyoda M, Shimizu J, Goto T, Shindo Y, Yoshimura K, Hatano E, Nagano H; Kansai Hepatobiliary Oncology Group (KHBO). Randomized phase III study of gemcitabine, cisplatin plus S-1 versus gemcitabine, cisplatin for advanced biliary tract cancer (KHBO1401- MITSUBA). J Hepatobiliary Pancreat Sci. 2023 Jan;30(1):102-110. doi: 10.1002/jhbp.1219. Epub 2022 Aug 9.
- Individual participant dataSharing planned: Yes. study protocol
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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.
Clinical Trial Center, National Cheng Kung University Hospital contact
Chia Jui Yen, MD., PhD principal investigator
Department on Oncology, National Cheng Kung University Hospital
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 Tislelizumab in people with Cholangiocarcinoma and Biliary Tract Cancer (BTC), run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 15 inclusion and 7 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: opening soon, as of the sponsor's last update on 30 Mar 2025. 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 Taiwan. 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 Clinical Trial Center, National Cheng Kung University Hospital (886-6-2353535 ext. 4289, ctcnckuh@mail.hosp.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: From enrollment to surgical resection at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06903273, which also lists 4 linked publications.
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 30 Mar 2025.