Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma

NCT05535647 | Unknown Phase 2

• 1 other identifier: E20220698
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, Two-arm, comparative, randomized, controlled phase II trial, to explore the efficacy and safety of Regorafenib and HAIC vs. FOLFOX as Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma.

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

Intrahepatic Cholangiocarcinoma; Regorafenib; HAIC; FOLFOX

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  the rate of complete response and partial response among all evaluable patients

  12month

Secondary Outcomes (4)

• Disease control rate (DCR)

  12 months

• Progression-free Survival (PFS)

  12 months

• Overall Survival (OS)

  24 months

• Adverse events (AE)

  24 months

Study Arms (2)

Regorafenib and HAIC

EXPERIMENTAL

Regorafenib HAIC with FOLFOX

Drug: Regorafenib and HAIC

FOLFOX

ACTIVE COMPARATOR

FOLFOX

Drug: FOLFOX

Interventions

Regorafenib and HAIC DRUG

Regorafenib: oral 80mg/day, D1-21, Q28d; HAIC with FOLFOX: hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 2400mg/m2 infusion 48h.

Regorafenib and HAIC

FOLFOX DRUG

Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 2400mg/m2 infusion 48h.

FOLFOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated IRB/IEC-approved Informed Consent.
• Cytological or histological diagnosis of locally advanced or metastatic adenocarcinoma of the Intrahepatic Cholangiocarcinoma.
• Disease progressing after first-line chemotherapy with gemcitabine and platinum analogs (only one prior systemic therapy allowed).
• Age 18-75 years
• Karnofsky Performance Status \> 50%
• Estimated life expectancy of at least 3 months.
• Negative pregnancy test (if female in reproductive years).
• Adequate bone marrow, liver and kidney function: leukocyte \> 3500/mm3; absolute neutrophil count (ANC) \> 1500/mm3; platelet count \> 100000/mm3; hemoglobin \> 10 g/dl; creatinine \< 1.5 mg/dL; total bilirubin ≤ 1.5 x upper limit of normal range (ULN); SGOT e SGPT ≤ 2.5 ULN
• At the time of start of treatment, at least 2 weeks must have elapsed since completion of prior chemotherapy, minor surgery and radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated).
• Resolution of all acute toxic effects of any prior chemotherapy, surgery or radiotherapy to NCI CTC (Version 4.03) grade ≤ 1 for hematologic toxicities and ≤ 2 for non hematologic toxicities, with the exception of alopecia.
• Able and willing to comply with scheduled visits, therapy plans, and laboratory tests required in this protocol.

You may not qualify if:

• History of cardiac disease
• Ongoing infection \> Grade 2 according to NCI-CTCAE version 4.03. Hepatitis B is allowed if no active replication (defined as abnormal ALT \>2xULN associated with HBV DNA \>20,000 IU/mL) is present
• Severe co-morbid illness and/or active infections including active hepatitis C and human immunodeficiency virus (HIV) infection
• History of interstitial lung disease (ILD).
• Any cancer curatively treated \< 3 years prior to study entry, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Staging: Ta, Tis and T1).
• Renal failure requiring hemo- or peritoneal dialysis.
• Clinically significant GI bleeding (CTCAE 4.03 grade 3 or higher) within 30 days prior to start of screening
• Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months prior to start of screening.
• History of organ allograft, cornea transplantation will be allowed
• Active CNS metastases not controllable with radiotherapy or corticosteroids Visible retinal pathology as assessed by ophthalmologic exam that is considered a risk factor for RVO or CSR.
• Known history of hypersensitivity to study drugs
• Non-healing wound, ulcer, or bone fracture.
• Patients with seizure disorder requiring medication.
• Acute steroid therapy or taper for any purpose (chronic steroid therapy is acceptable provided that the dose is stable for 1 month before start of screening and thereafter).
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

regorafenib; Folfox protocol

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: September 25, 2022
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2025
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)