Biliary Tract CancerNCT07156058
MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer
A study testing MiniPDX group and Capecitabine in people with Biliary Tract Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This research aims to study the effect of postoperative adjuvant therapy with a MiniPDX drug sensitivity test for biliary tract cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- MiniPDX group and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- 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
- histologically documented biliary duct cancer (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma and gallbladder carcinoma). Patients underwent R0 resection.
- Ambulatory male or female. Age ≥ 18 years.
- ECOG performance status between 0 and 2
- Patients must be tolerated with combination treatment with life expectancy of greater than 6 months.
- No dysfunction and bleeding tendency in main organs (heart, liver, brain and kidneys); No history of blood disease; No cardiac insufficiency or chest pain (medically uncontrollable). No myocardial infarction occurred within 12 months before the start of the study.
- Subjects must have normal organ as defined below: Hb ≥80 g/L; ANC ≥1.5×109/L; Platelets ≥100×109/L; AL/AST ≤2.5 x institutional upper limit of normal; ALP ≤2.5 x ULN; Total bilirubin <1.5 x ULN; Creatinine <1 x ULN; Serum albumin ≥30g/L.
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- Women of child-bearing potential must agree to use adequate contraception (IUD, contraceptives or condoms) for the duration of study participation, and for 6 months after completion of study; Serum or urine pregnancy tests are negative within 7 days before study entry; men must agree to use adequate contraception for the duration of study participation, and for 6 months after completion of study.
- Patients must be willing to and able to follow the protocol during study entry.
- Patients must be willing to sign an informed consent and able to understand that anytime is all right to quit the study without loss.
Who cannot join
- Prior chemotherapy or radiotherapy.
- Patients are in other clinical trials.
- Coagulation disorders, history of blood disease or serious (active) heart disease such as coronary heart disease with apparent symptom, congestive heart failure of NYHA Class II or more severe, serious heart rhythm controlled by medicaments, or the attack of myocardial infarction within 12 months.
- Hepatic and renal insufficiency with apparent symptom.
- Pregnant or lactating female, or women of child-bearing age who have a positive serum pregnancy test or no tests. Female subjects of non-reproductive potential with post-menopausal for ≥1 year.
- Patients with multiple primary cancer, or brain or meningeal metastases.
Show all 10Show fewer
- Patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity, as judged by the investigator, may hinder the signing of informed consent or affect the patient's compliance with oral medication
- Patients who need immunotherapy for organ transplantation.
- Patients with recurrent infections, or other uncontrolled accompanying diseases, or hepatic cirrhosis caused hepatic injury or chronic active hepatitis (ALT ≥2 ULN, AST ≥1.5 ULN, PT >13 S or TB ≥2 ULN)
- Moderate or severe kidney injury [CrCl ≤50 ml/min (Cockcroft-Gault Equation)], or creatinine > ULN
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, 100021
Xinyu Bi, M.D.
About this study
Official title: MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer: A Prospective Cohort Study
This research aims to study the effect of postoperative adjuvant therapy with a MiniPDX drug sensitivity test for biliary tract cancer.
Read the detailed description
Biliary tract cancer (BTC) is the most common primary malignancy of the biliary tract. Currently, surgery provides the only ray of hope for the management of BTC, however, the disease is progressing rapidly, lacking of obvious symptoms in its early stages, with metastases to lymph nodes. Only 20-30% of patients are eligible for surgical resection with curative intent. In addition, the treatment remains difficult because of the lack of effective chemotherapeutic agents and the combined regimens for reference.
In this study, fresh tumor samples generated directly from patients will be used for a MiniPDX test and inoculated in mice subcutaneously. The candidate drugs or regimens can be tested in mice to determine the best treatment for that specific patient after surgery.
The study aims to evaluate the efficacy and accuracy of MiniPDX assays for antitumor chemotherapeutics.
- Conditions
- Biliary Tract Cancer
- Being tested
- MiniPDX group, Capecitabine
- 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.
MiniPDX groupOther
Personalized treatment for guided by mini-PDX. The MiniPDX test can provide drug sensitivity results in as little as 7 days. Drugs including but not limited to the following agents: capecitabine, gemcitabine + cis-platinum, gemcitabine + capecitabine, 5-FU + oxaliplatin, gemcitabine, 5-FU, capecitabine + cis-platinum, 5-FU + cis-platinum.
CapecitabineDrug
Drug: Capecitabine
| Study group | Role | What they receive |
|---|---|---|
| MiniPDX group | Experimental | 102 patients with BTC after surgery will be treated with drugs or regimens tested by MiniPDX assays. Receives: Other: MiniPDX group |
| Treatment of Physician's Choice (TPC) | Active comparator | TPC will be administered per standard of care. 102 patients after surgery in the same period will receive chemotherapy. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-Free Survival (RFS)
The interval from surgery to diagnosis of recurrence in the patients enrolled.
Measured: Through study completion, an expected average of 2 year.
Secondary outcomes (4)
Overall Survival (OS)
The interval from randomization until death, whichever comes first.
Measured: Through study completion, an expected average of 2 year.
Event-Free Survival (EFS)
The time from randomization to initial occurrence (including local recurrence, metastasis, second primary cancer, death or any cause among the above), whichever comes first.
Measured: Through study completion, an expected average of 2 year.
Non-recurrence after radical surgery for BTC in 2 years
The ratio of patients with BTC after radical surgery without recurrence in 2 years.
Measured: Through study completion, an expected average of 2 year.
Quality of Life (QOL)
Assessed by the EORTC QLQ-C30 for patients over 16 years old) or the Pediatric Quality of Life Inventory (PedsQL) for patients under 16 years old.
Measured: Through study completion, an expected average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Jan 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinyu Bi, M.D., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156058
- Sponsor's protocol ID
- LC2022A04
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Valle JW, Kelley RK, Nervi B, Oh DY, Zhu AX. Biliary tract cancer. Lancet. 2021 Jan 30;397(10272):428-444. doi: 10.1016/S0140-6736(21)00153-7.
PubMed 33516341Mizrahi JD, Shroff RT. New Treatment Options for Advanced Biliary Tract Cancer. Curr Treat Options Oncol. 2020 Jun 29;21(8):63. doi: 10.1007/s11864-020-00767-3.
PubMed 32602010Mondaca S, Nervi B, Pinto M, Abou-Alfa GK. Biliary tract cancer prognostic and predictive genomics. Chin Clin Oncol. 2019 Aug;8(4):42. doi: 10.21037/cco.2019.07.06. Epub 2019 Jul 29.
PubMed 31431036Nara S, Esaki M, Ban D, Takamoto T, Shimada K, Ioka T, Okusaka T, Ishii H, Furuse J. Adjuvant and neoadjuvant therapy for biliary tract cancer: a review of clinical trials. Jpn J Clin Oncol. 2020 Dec 16;50(12):1353-1363. doi: 10.1093/jjco/hyaa170.
PubMed 33037430Bridgewater 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 27249723Persano M, Puzzoni M, Ziranu P, Pusceddu V, Lai E, Pretta A, Donisi C, Pinna G, Spanu D, Cimbro E, Parrino A, Liscia N, Mariani S, Dubois M, Migliari M, Scartozzi M. Molecular-driven treatment for biliary tract cancer: the promising turning point. Expert Rev Anticancer Ther. 2021 Nov;21(11):1253-1264. doi: 10.1080/14737140.2021.1982699. Epub 2021 Sep 24.
PubMed 34551663Lamarca A, Barriuso J, McNamara MG, Valle JW. Molecular targeted therapies: Ready for "prime time" in biliary tract cancer. J Hepatol. 2020 Jul;73(1):170-185. doi: 10.1016/j.jhep.2020.03.007. Epub 2020 Mar 12.
PubMed 32171892Scott AJ, Sharman R, Shroff RT. Precision Medicine in Biliary Tract Cancer. J Clin Oncol. 2022 Aug 20;40(24):2716-2734. doi: 10.1200/JCO.21.02576. Epub 2022 Jul 15.
PubMed 35839428Zhang F, Wang W, Long Y, Liu H, Cheng J, Guo L, Li R, Meng C, Yu S, Zhao Q, Lu S, Wang L, Wang H, Wen D. Characterization of drug responses of mini patient-derived xenografts in mice for predicting cancer patient clinical therapeutic response. Cancer Commun (Lond). 2018 Sep 26;38(1):60. doi: 10.1186/s40880-018-0329-5.
PubMed 30257718Raja FA, Counsell N, Colombo N, Pfisterer J, du Bois A, Parmar MK, Vergote IB, Gonzalez-Martin A, Alberts DS, Plante M, Torri V, Ledermann JA. Platinum versus platinum-combination chemotherapy in platinum-sensitive recurrent ovarian cancer: a meta-analysis using individual patient data. Ann Oncol. 2013 Dec;24(12):3028-34. doi: 10.1093/annonc/mdt406. Epub 2013 Nov 4.
PubMed 24190964Vlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernandez-Mateos J, Khan K, Lampis A, Eason K, Huntingford I, Burke R, Rata M, Koh DM, Tunariu N, Collins D, Hulkki-Wilson S, Ragulan C, Spiteri I, Moorcraft SY, Chau I, Rao S, Watkins D, Fotiadis N, Bali M, Darvish-Damavandi M, Lote H, Eltahir Z, Smyth EC, Begum R, Clarke PA, Hahne JC, Dowsett M, de Bono J, Workman P, Sadanandam A, Fassan M, Sansom OJ, Eccles S, Starling N, Braconi C, Sottoriva A, Robinson SP, Cunningham D, Valeri N. Patient-derived organoids model treatment response of metastatic gastrointestinal cancers. Science. 2018 Feb 23;359(6378):920-926. doi: 10.1126/science.aao2774.
PubMed 29472484Lee SH, Hu W, Matulay JT, Silva MV, Owczarek TB, Kim K, Chua CW, Barlow LJ, Kandoth C, Williams AB, Bergren SK, Pietzak EJ, Anderson CB, Benson MC, Coleman JA, Taylor BS, Abate-Shen C, McKiernan JM, Al-Ahmadie H, Solit DB, Shen MM. Tumor Evolution and Drug Response in Patient-Derived Organoid Models of Bladder Cancer. Cell. 2018 Apr 5;173(2):515-528.e17. doi: 10.1016/j.cell.2018.03.017.
PubMed 29625057Sachs N, de Ligt J, Kopper O, Gogola E, Bounova G, Weeber F, Balgobind AV, Wind K, Gracanin A, Begthel H, Korving J, van Boxtel R, Duarte AA, Lelieveld D, van Hoeck A, Ernst RF, Blokzijl F, Nijman IJ, Hoogstraat M, van de Ven M, Egan DA, Zinzalla V, Moll J, Boj SF, Voest EE, Wessels L, van Diest PJ, Rottenberg S, Vries RGJ, Cuppen E, Clevers H. A Living Biobank of Breast Cancer Organoids Captures Disease Heterogeneity. Cell. 2018 Jan 11;172(1-2):373-386.e10. doi: 10.1016/j.cell.2017.11.010. Epub 2017 Dec 7.
PubMed 29224780Bruna A, Rueda OM, Greenwood W, Batra AS, Callari M, Batra RN, Pogrebniak K, Sandoval J, Cassidy JW, Tufegdzic-Vidakovic A, Sammut SJ, Jones L, Provenzano E, Baird R, Eirew P, Hadfield J, Eldridge M, McLaren-Douglas A, Barthorpe A, Lightfoot H, O'Connor MJ, Gray J, Cortes J, Baselga J, Marangoni E, Welm AL, Aparicio S, Serra V, Garnett MJ, Caldas C. A Biobank of Breast Cancer Explants with Preserved Intra-tumor Heterogeneity to Screen Anticancer Compounds. Cell. 2016 Sep 22;167(1):260-274.e22. doi: 10.1016/j.cell.2016.08.041. Epub 2016 Sep 15.
PubMed 27641504Marangoni E, Vincent-Salomon A, Auger N, Degeorges A, Assayag F, de Cremoux P, de Plater L, Guyader C, De Pinieux G, Judde JG, Rebucci M, Tran-Perennou C, Sastre-Garau X, Sigal-Zafrani B, Delattre O, Dieras V, Poupon MF. A new model of patient tumor-derived breast cancer xenografts for preclinical assays. Clin Cancer Res. 2007 Jul 1;13(13):3989-98. doi: 10.1158/1078-0432.CCR-07-0078.
PubMed 17606733
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07156058
- Acronym / sponsor ID
- LC2022A04
- Conditions
- Biliary Tract Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Sep 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.
This research aims to study the effect of postoperative adjuvant therapy with a MiniPDX drug sensitivity test for biliary tract cancer.
Detailed description
Biliary tract cancer (BTC) is the most common primary malignancy of the biliary tract. Currently, surgery provides the only ray of hope for the management of BTC, however, the disease is progressing rapidly, lacking of obvious symptoms in its early stages, with metastases to lymph nodes. Only 20-30% of patients are eligible for surgical resection with curative intent. In addition, the treatment remains difficult because of the lack of effective chemotherapeutic agents and the combined regimens for reference.
In this study, fresh tumor samples generated directly from patients will be used for a MiniPDX test and inoculated in mice subcutaneously. The candidate drugs or regimens can be tested in mice to determine the best treatment for that specific patient after surgery.
The study aims to evaluate the efficacy and accuracy of MiniPDX assays for antitumor chemotherapeutics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MiniPDX group | Experimental | Other: MiniPDX group102 patients with BTC after surgery will be treated with drugs or regimens tested by MiniPDX assays. |
| Treatment of Physician's Choice (TPC) | Active comparator | Drug: CapecitabineTPC will be administered per standard of care. 102 patients after surgery in the same period will receive chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- histologically documented biliary duct cancer (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma and gallbladder carcinoma). Patients underwent R0 resection.
- Ambulatory male or female. Age ≥ 18 years.
- ECOG performance status between 0 and 2
- Patients must be tolerated with combination treatment with life expectancy of greater than 6 months.
- No dysfunction and bleeding tendency in main organs (heart, liver, brain and kidneys); No history of blood disease; No cardiac insufficiency or chest pain (medically uncontrollable). No myocardial infarction occurred within 12 months before the start of the study.
Key exclusion criteria (10 listed)
- Prior chemotherapy or radiotherapy.
- Patients are in other clinical trials.
- Coagulation disorders, history of blood disease or serious (active) heart disease such as coronary heart disease with apparent symptom, congestive heart failure of NYHA Class II or more severe, serious heart rhythm controlled by medicaments, or the attack of myocardial infarction within 12 months.
- Hepatic and renal insufficiency with apparent symptom.
- Pregnant or lactating female, or women of child-bearing age who have a positive serum pregnancy test or no tests. Female subjects of non-reproductive potential with post-menopausal for ≥1 year.
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 |
|---|---|---|
| MiniPDX groupPersonalized treatment for guided by mini-PDX. The MiniPDX test can provide drug sensitivity results in as little as 7 days. Drugs including but not limited to the following agents: capecitabine, gemcitabine + cis-platinum, gemcitabine + capecitabine, 5-FU + oxaliplatin, gemcitabine, 5-FU, capecitabine + cis-platinum, 5-FU + cis-platinum. | Other | MiniPDX group |
| CapecitabineDrug: Capecitabine | Drug | Treatment of Physician's Choice (TPC) |
Primary outcome
Relapse-Free Survival (RFS)
Time frame: Through study completion, an expected average of 2 year.
The interval from surgery to diagnosis of recurrence in the patients enrolled.
4 secondary outcomes
Overall Survival (OS)
Time frame: Through study completion, an expected average of 2 year.
Event-Free Survival (EFS)
Time frame: Through study completion, an expected average of 2 year.
Non-recurrence after radical surgery for BTC in 2 years
Time frame: Through study completion, an expected average of 2 year.
Quality of Life (QOL)
Time frame: Through study completion, an expected average of 2 year.
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 4 Sep 2025.
- Background: PubMed 33516341Valle JW, Kelley RK, Nervi B, Oh DY, Zhu AX. Biliary tract cancer. Lancet. 2021 Jan 30;397(10272):428-444. doi: 10.1016/S0140-6736(21)00153-7.
- Background: PubMed 32602010Mizrahi JD, Shroff RT. New Treatment Options for Advanced Biliary Tract Cancer. Curr Treat Options Oncol. 2020 Jun 29;21(8):63. doi: 10.1007/s11864-020-00767-3.
- Background: PubMed 31431036Mondaca S, Nervi B, Pinto M, Abou-Alfa GK. Biliary tract cancer prognostic and predictive genomics. Chin Clin Oncol. 2019 Aug;8(4):42. doi: 10.21037/cco.2019.07.06. Epub 2019 Jul 29.
- Background: PubMed 33037430Nara S, Esaki M, Ban D, Takamoto T, Shimada K, Ioka T, Okusaka T, Ishii H, Furuse J. Adjuvant and neoadjuvant therapy for biliary tract cancer: a review of clinical trials. Jpn J Clin Oncol. 2020 Dec 16;50(12):1353-1363. doi: 10.1093/jjco/hyaa170.
- Background: PubMed 27249723Bridgewater 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.
- Background: PubMed 34551663Persano M, Puzzoni M, Ziranu P, Pusceddu V, Lai E, Pretta A, Donisi C, Pinna G, Spanu D, Cimbro E, Parrino A, Liscia N, Mariani S, Dubois M, Migliari M, Scartozzi M. Molecular-driven treatment for biliary tract cancer: the promising turning point. Expert Rev Anticancer Ther. 2021 Nov;21(11):1253-1264. doi: 10.1080/14737140.2021.1982699. Epub 2021 Sep 24.
- Background: PubMed 32171892Lamarca A, Barriuso J, McNamara MG, Valle JW. Molecular targeted therapies: Ready for "prime time" in biliary tract cancer. J Hepatol. 2020 Jul;73(1):170-185. doi: 10.1016/j.jhep.2020.03.007. Epub 2020 Mar 12.
- Background: PubMed 35839428Scott AJ, Sharman R, Shroff RT. Precision Medicine in Biliary Tract Cancer. J Clin Oncol. 2022 Aug 20;40(24):2716-2734. doi: 10.1200/JCO.21.02576. Epub 2022 Jul 15.
- Background: PubMed 30257718Zhang F, Wang W, Long Y, Liu H, Cheng J, Guo L, Li R, Meng C, Yu S, Zhao Q, Lu S, Wang L, Wang H, Wen D. Characterization of drug responses of mini patient-derived xenografts in mice for predicting cancer patient clinical therapeutic response. Cancer Commun (Lond). 2018 Sep 26;38(1):60. doi: 10.1186/s40880-018-0329-5.
- Background: PubMed 24190964Raja FA, Counsell N, Colombo N, Pfisterer J, du Bois A, Parmar MK, Vergote IB, Gonzalez-Martin A, Alberts DS, Plante M, Torri V, Ledermann JA. Platinum versus platinum-combination chemotherapy in platinum-sensitive recurrent ovarian cancer: a meta-analysis using individual patient data. Ann Oncol. 2013 Dec;24(12):3028-34. doi: 10.1093/annonc/mdt406. Epub 2013 Nov 4.
- Background: PubMed 29472484Vlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernandez-Mateos J, Khan K, Lampis A, Eason K, Huntingford I, Burke R, Rata M, Koh DM, Tunariu N, Collins D, Hulkki-Wilson S, Ragulan C, Spiteri I, Moorcraft SY, Chau I, Rao S, Watkins D, Fotiadis N, Bali M, Darvish-Damavandi M, Lote H, Eltahir Z, Smyth EC, Begum R, Clarke PA, Hahne JC, Dowsett M, de Bono J, Workman P, Sadanandam A, Fassan M, Sansom OJ, Eccles S, Starling N, Braconi C, Sottoriva A, Robinson SP, Cunningham D, Valeri N. Patient-derived organoids model treatment response of metastatic gastrointestinal cancers. Science. 2018 Feb 23;359(6378):920-926. doi: 10.1126/science.aao2774.
- Background: PubMed 29625057Lee SH, Hu W, Matulay JT, Silva MV, Owczarek TB, Kim K, Chua CW, Barlow LJ, Kandoth C, Williams AB, Bergren SK, Pietzak EJ, Anderson CB, Benson MC, Coleman JA, Taylor BS, Abate-Shen C, McKiernan JM, Al-Ahmadie H, Solit DB, Shen MM. Tumor Evolution and Drug Response in Patient-Derived Organoid Models of Bladder Cancer. Cell. 2018 Apr 5;173(2):515-528.e17. doi: 10.1016/j.cell.2018.03.017.
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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.
Xinyu Bi, M.D. principal investigator
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 study testing MiniPDX group and Capecitabine 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 10 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 4 Sep 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 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?
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 Xinyu Bi, M.D. (13911792177, beexy1971@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-Free Survival (RFS) (time frame: Through study completion, an expected average of 2 year.). 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 NCT07156058, which also lists 25 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 4 Sep 2025.