Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma

Khon Kaen University

Status and phase: Unknown; Phase 2

Conditions: Cholangiocarcinoma

Treatments: Drug: mFOLFOXIRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03603834

HE611336

Details and patient eligibility

About

Previous reports suggest benefit of neoadjuvant chemotherapy/chemoradiation treatment for borderline resectable cholangiocarcinoma. This study is a single center prospective phase II study of neoadjuvant chemotherapy with mFOLFOXIRI in patients with borderline resectable cholangiocarcinoma.

Full description

Previous reports suggest benefit of neoadjuvant chemotherapy/chemoradiation treatment for borderline resectable cholangiocarcinoma.

This study is a single center prospective phase II study of neoadjuvant chemotherapy with mFOLFOXIRI in patients with borderline resectable cholangiocarcinoma.

This phase 2 trial was designed to enroll 25 patients with BRCC who were assigned to mFOLFOXIRI neoadjuvant chemotherapy. The primary endpoint was the overall response rate.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 18 years old at the time of informed consent

2. Diagnosed with cholangiocarcinoma and the disease is measurable by RECIST 1.1 criteria

3. ECOG performance status of 0 or 1

4. No distant metastasis

5. The disease is either resectable or potentially resectable

6. Patients must have adequate organ function as defined by the following laboratory values at study entry:

   Hemoglobin ≥ 8 g/dL (transfusions are acceptable) ANC ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L AST/ALT ≤ 3 x ULN Total bilirubin ≤ 2.5 mg/dL Creatinine clearance ≥ 50 mL/min (estimated by Cockcroft-Gault or measured)

7. Women of childbearing potential definition (WOCBP) and men must agree to use adequate contraception prior, to study entry, for the duration of study participation, and 3 months after the end of treatment.

8. WOCBP must have a negative serum or urine pregnancy test prior to initiation of treatment.

Exclusion criteria

1. > 75 years old
2. Prior therapy for cholangiocarcinoma with either surgery, radiation or chemotherapy
3. Other malignancies except for the following: adequately treated cervical carcinoma in situ and treated basal cell carcinoma.
4. Hypersensitivity to 5FU, oxaliplatin (or other platinum agents), irinotecan (or to their excipients).
5. Pregnant or lactating women.
6. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
7. Liver disease including but not limited to cirrhosis, primary sclerosing cholangitis, future liver remnant of less than 20-30%
8. Comorbidity including but not limited to active clinically serious infections, congestive heart failure, life-threatening arrhythmia
9. known HIV positive
10. Baseline peripheral neuropathy/paresthesia grade ≥ 2.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

mFOLFOXIRI

Experimental group

Description:

mFOLFOXIRI consists of the following combination of drugs: Oxaliplatin, 85 mg/m2, IV over 2 hours Leucovorin, 400 mg/m2, IV over 2 hours Irinotecan, 150 mg/m2, IV over 90 minutes 5 FU, 400 mg/m2, IV bolus 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection each 14 day cycle, for 6 cycles

Treatment:

Drug: mFOLFOXIRI