WithdrawnPhase 2

Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, The OPTIC Trial

Stopped: PI has decided to terminate this study due to study supporter pulling support on this study.

0Started 2024-03-01

Plain-language summary

This phase II trial assesses the feasibility (including both safety and tolerability) of conducting Next Generation Sequencing and administering targeted therapy (infigratinib) in the preoperative setting for patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Chemotherapy drugs, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Targeted therapy with infigratinib will bind to FGFR which can help stop tumor cell growth and cause tumor cell death. Giving chemotherapy and/or targeted therapy before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. If a molecular profiling test shows a genetic change called an FGFR2 fusion, patients receive both chemotherapy and targeted therapy while patients without a FGFR2 fusion just receive chemotherapy. Giving targeted therapy based on molecular profile testing results prior to attempted resection of an intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of intrahepatic cholangiocarcinoma * High-quality cross-sectional imaging by computerized tomography (CT) or magnetic resonant imaging (MRI) performed within 6 weeks prior to enrollment and showed a resectable IHCCA confined to the liver, bile duct, and /or regional lymph nodes. No distant extrahepatic disease is allowed. * Adults \> 18 years of age * Able to give informed consent * Able to adhere to study visit schedule and other protocol requirements * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Adequate bone marrow reserves as evidenced by: * Absolute neutrophil count (ANC) ≥1,500 cells/ul * Platelet count ≥100,000 cells/μl * Hemoglobin ≥9 g/dL * Adequate hepatic function as evidenced by: * Serum total bilirubin ≤1.5 x ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN * Albumin ≥3 g/dl * Adequate renal function as evidenced by creatinine ≤1.5 x ULN * Creatinine =\< 1.5 x ULN * Have amylase or lipase \< 2.0 x ULN * Male, or a non-pregnant and non-lactating female * Women of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy \[the surgical removal of the uterus\] or bilateral oophorectomy \[the surgical removal of both ovaries\] or (2) has not been naturally postmenopausal for at least 24 consecutive months \[i.e., has had menses at any time during the preceding 24 consecutive months\]) must commit to true abstinence from heterosexual …

What they're measuring

Feasibility of Completing All Preoperative Testing and Therapy

Timeframe: Up to 3 years

Unacceptable Toxicity

Timeframe: Up to 3 years

Safety and Tolerability

Timeframe: Up to 3 years

Trial details

NCT IDNCT05514912

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-23

View on ClinicalTrials.gov More Resectable Intrahepatic Cholangiocarcinoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.