Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for Intrahepatic Cholangiocarcinoma

NCT05124002 | Recruiting Phase 4

• 1 other identifier: 21325-2-02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Oncolytic viruses can selectively replicate in and destroy tumor cells. Recent studies indicate that recombinant human adenovirus type 5 (H101), which is the first approved oncolytic virus drug in the world, shows anti-tumor effects on liver cancer. This study aims to further verify the effect and safety of recombinant human adenovirus type 5 combined with HAIC in the treatment of intrahepatic mass-forming cholangiocarcinoma.

Conditions

Cholangiocarcinoma, Intrahepatic

Keywords

oncolytic virus; intrahepatic mass-forming cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  The median amount of time from registration until disease progression or death, whichever occurs first. Disease progression was assessed via RECIST 1.1 criteria.

  up to 1 month

Secondary Outcomes (3)

• 1 year survival rate

  1 year

• Objective response rate (ORR)

  up to 1month

• Disease control rate (DCR)

  up to 1 month

Study Arms (1)

H101+HAIC

EXPERIMENTAL

Recombinant Human Adenovirus Type 5 (H101): intratumorally injected 3 days before HAIC. 1 vial (5.0 × 10\^11 vp) if the maximum diameters of lesion ≤ 5 cm, 2 vials (1.0 × 10\^12 vp) if the maximum diameters of lesion ≤ 10 cm, 3 vials (1.5 × 10\^12 vp) if the maximum diameters of lesion is \> 10 cm. HAIC (FOLFOX): Oxaliplatin 50 mg + 5-FU 1.5 g + leucovorin calcium

Drug: Recombinant Human Adenovirus Type 5; Drug: HAIC of FOLFOX

Interventions

Recombinant Human Adenovirus Type 5 DRUG

H101 will be intratumorally injected 3 days before HAIC. Dosage of H101: 1 vial (5.0 × 10\^11 vp) if the maximum diameters of lesion ≤ 5 cm, 2 vials (1.0 × 10\^12 vp) if the maximum diameters of lesion ≤ 10 cm, 3 vials (1.5 × 10\^12 vp) if the maximum diameters of lesion is \> 10 cm.

Also known as: H101

H101+HAIC

HAIC of FOLFOX DRUG

Oxaliplatin 50 mg + 5-FU 1.5 g + leucovorin calcium. The infusion will be continued for 2-3 days according to patients' tolerance and tumor conditions. The standard treatment for HAIC consists of 4-6 cycles, with the second cycle being 3 weeks after the end of the first HAIC cycle and the subsequent cycles being 4 weeks after the end of the previous HAIC.

Also known as: FOLFOX

H101+HAIC

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years, male or female
• Histologically or cytologically confirmed intrahepatic mass-forming cholangiocarcinoma (IMCC) with unresectable lesion(s) or patients who refuse surgery
• At least one measurable lesion according RECIST v1.1 criteria \[spiral CT/MRI scan ≥ 10 mm (CT scan slice thickness no greater than 5 mm)\]
• Life expectancy ≥ 3 months
• The function of vital organs meets the following requirements: absolute neutrophil count (ANC) ≥ 3.5 × 10\^9/L; platelets ≥ 125 × 10\^9/L; hemoglobin ≥ 8 g/dL; Serum albumin ≥ 2.8 g/dL; bilirubin ≤ 3 ULN, ALT/AST ≤ 2.5 ULN; ALT/AST in the presence of liver metastases ≤ 5 ULN; creatinine ≤ 1.5 ULN; euthyroid; LVEF \> 50%
• The date of the first dose of study drug is ≥ 21 days from the date of previous anti-tumor treatment, and has recovered from adverse reactions to prior anti-tumor therapy to baseline or lower than grade 1 (according to CTCAE Version 5.0)(except alopecia)
• Female patients of childbearing potential (including early menopause, menopause \< 2 years, and non-surgical sterilization), male patients and their partners must agree to use effective contraceptive measures during the study
• Patients or their legal representatives can understand and offer informed consent, being willing to take part in the follow-up with good compliance

You may not qualify if:

• Pregnant or lactating women, men or women who are reluctant to take effective contraceptive measures
• Previous treatment with oncolytic viruses (such as T-VEC)
• Abnormal coagulation function, or having a bleeding tendency, or receiving thrombolytic or anticoagulant therapy
• Patients with poor glycemic control
• Known central nervous system tumors, including metastatic brain tumors
• Accompanied by any unstable systemic diseases, including but not limited to severe infection, resistant hypertension, unstable angina, stroke or myocardial infarction within 6 months, congestive heart failure, and serious cardiac arrhythmia requiring medication, renal or metabolic disease requiring medication
• Known hypersensitivity to the study drug or oxaliplatin, leucovorin calcium, fluorouracil
• History of immunodeficiency or autoimmune disease, or receiving long-term systemic steroid therapy within 7 days before enrollment, or any form of immunosuppressive therapy
• Other conditions that are not suitable for participating in this trial

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

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

Study Officials

• ZHANG YUEWEI, MD

  Beijing Tsinghua Chang Gung Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Tianxiao, MD

CONTACT

0086-13969193950; wtx419@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: HAIC (FOLFOX) + H101

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: November 17, 2021
• Study Start: August 1, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2023-08

Locations

CN (1)