MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer

Официальное название

MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer: A Prospective Cohort Study

Обзор

This research aims to study the effect of postoperative adjuvant therapy with a MiniPDX drug sensitivity test for biliary tract cancer.

Подробное описание

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.

Вмешательства

• Другое MiniPDX group
  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.
• Препарат Capecitabine
  Drug: Capecitabine

Первичные конечные точки

• Relapse-Free Survival (RFS) [Срок оценки: Through study completion, an expected average of 2 year.]

Вторичные конечные точки (4)

• Overall Survival (OS) [Срок оценки: Through study completion, an expected average of 2 year.]
• Event-Free Survival (EFS) [Срок оценки: Through study completion, an expected average of 2 year.]
• Non-recurrence after radical surgery for BTC in 2 years [Срок оценки: Through study completion, an expected average of 2 year.]
• Quality of Life (QOL) [Срок оценки: Through study completion, an expected average of 2 year.]

Критерии участия

Критерии включения

• 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.
• 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.

Критерии исключения

• 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.
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Пекин

Публикации

• 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. PMID 33516341
• Mizrahi 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. PMID 32602010
• Mondaca 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. PMID 31431036
• Nara 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. PMID 33037430
• Bridgewater 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. PMID 27249723
• Persano 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. PMID 34551663
• Lamarca 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. PMID 32171892
• Scott 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. PMID 35839428

Идентификаторы

NCT: NCT07156058 · LC2022A04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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