Clinical Feasibility of Nab-paclitaxel Plus Gemcitabine-cisplatin Chemotherapy in Locally Advanced Cholangiocarcinoma

NCT05677217 | Recruiting

• 1 other identifier: 2022-11-002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this observational study is to identify patients with locally advanced cholangiocarcinoma treated with nab-paclitaxel and gemcitabine-cisplatin chemotherapy. In this clinical study, peripheral blood and tumor tissues will be analyzed at baseline and every 3 cycles after systemic drug treatment in patients with locally advanced cholangiocarcinoma, and correlation with treatment was analyzed. This is an exploratory study to discover biomarkers that are highly correlated with treatment response.

Conditions

Locally Advanced Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Conversion Surgery Rate

  Proportion of patients who underwent conversion surgery

  6 months

Secondary Outcomes (3)

• OS

  2 years

• ORR

  1 year

• PFS

  2 years

Other Outcomes (3)

• Recurrence Rate

  through study completion, an average of 1 year

• Change of ctDNA

  From baseline to 1 year of treatment

• Identification of potential Biomarkers of Conversion Surgery

  From baseline to 1 year of treatment

Study Arms (1)

nab-paclitaxel plus gemcitabine-cisplatin

gemcitabine, 800 mg/m2, cisplatin, 25 mg/m2, and nab-paclitaxel, 100 mg/m2, on days 1 and 8 of 21-day cycles

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment of advanced cholangiocarcinoma patients through a competitive registration process at CHA Bundang Hospital, Haeundae Paik Hospital, and Seoul National University Bundang Hospital.

You may qualify if:

• Those above the age of 19 who understand the purpose of the study and agree to participate in the collection of samples during the study.
• Patients with histologically or cytologically confirmed inoperable locally advanced cholangiocarcinoma (gallbladder cancer, extrahepatic biliary tract cancer, intrahepatic biliary tract cancer)
• Patients who underwent an NGS test with advanced cholangiocarcinoma tissues
• Patients planning to be treated with nab-paclitaxel plus gemcitabine-cisplatin combination therapy
• ECOG performance status 0 or 1

You may not qualify if:

• Systemic condition accompanied by instability of vital signs such as infection or organ failure
• Patients who have previously received palliative chemotherapy for cholangiocarcinoma
• Those with mental/neurological conditions or dementia who have difficulties understanding and completing the consent form
• Those who are assessed as not suitable for this study, at the discretion of the researcher

Sponsors & Collaborators

• CHA University: lead

Study Sites (1)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

RECRUITING

Related Publications (7)

• Jarnagin WR, Fong Y, DeMatteo RP, Gonen M, Burke EC, Bodniewicz BS J, Youssef BA M, Klimstra D, Blumgart LH. Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma. Ann Surg. 2001 Oct;234(4):507-17; discussion 517-9. doi: 10.1097/00000658-200110000-00010.

  PMID: 11573044 BACKGROUND

• Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.

  PMID: 20375404 BACKGROUND

• Kim BJ, Hyung J, Yoo C, Kim KP, Park SJ, Lee SS, Park DH, Song TJ, Seo DW, Lee SK, Kim MH, Park JH, Cho H, Ryoo BY, Chang HM. Prognostic factors in patients with advanced biliary tract cancer treated with first-line gemcitabine plus cisplatin: retrospective analysis of 740 patients. Cancer Chemother Pharmacol. 2017 Jul;80(1):209-215. doi: 10.1007/s00280-017-3353-2. Epub 2017 Jun 8.

  PMID: 28597043 BACKGROUND

• Shroff RT, Javle MM, Xiao L, Kaseb AO, Varadhachary GR, Wolff RA, Raghav KPS, Iwasaki M, Masci P, Ramanathan RK, Ahn DH, Bekaii-Saab TS, Borad MJ. Gemcitabine, Cisplatin, and nab-Paclitaxel for the Treatment of Advanced Biliary Tract Cancers: A Phase 2 Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):824-830. doi: 10.1001/jamaoncol.2019.0270.

  PMID: 30998813 BACKGROUND

• Tie J, Cohen JD, Lahouel K, Lo SN, Wang Y, Kosmider S, Wong R, Shapiro J, Lee M, Harris S, Khattak A, Burge M, Harris M, Lynam J, Nott L, Day F, Hayes T, McLachlan SA, Lee B, Ptak J, Silliman N, Dobbyn L, Popoli M, Hruban R, Lennon AM, Papadopoulos N, Kinzler KW, Vogelstein B, Tomasetti C, Gibbs P; DYNAMIC Investigators. Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer. N Engl J Med. 2022 Jun 16;386(24):2261-2272. doi: 10.1056/NEJMoa2200075. Epub 2022 Jun 4.

  PMID: 35657320 BACKGROUND

• Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.

  PMID: 27384348 BACKGROUND

• Cheon J, Lee CK, Sang YB, Choi HJ, Kim MH, Ji JH, Ko KH, Kwon CI, Kim DJ, Choi SH, Kim C, Kang B, Chon HJ. Real-world efficacy and safety of nab-paclitaxel plus gemcitabine-cisplatin in patients with advanced biliary tract cancers: a multicenter retrospective analysis. Ther Adv Med Oncol. 2021 Aug 7;13:17588359211035983. doi: 10.1177/17588359211035983. eCollection 2021.

  PMID: 34394748 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and, if available, tissue samples

Study Officials

• Hong Jae Chon, MD,PhD

  CHA Bundang Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Jae Chon, MD,PhD

CONTACT

82-031-780-3928; minidoctor@cha.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: January 10, 2023
• Study Start: March 20, 2023
• Primary Completion: September 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)