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

Primary Purpose

Cholangiocarcinoma, Intrahepatic

Status

Not yet recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Recombinant Human Adenovirus Type 5

HAIC of FOLFOX

About this trial

This is an interventional treatment trial for Cholangiocarcinoma, Intrahepatic focused on measuring oncolytic virus, intrahepatic mass-forming cholangiocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Beijing Tsinghua Chang Gung Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

H101+HAIC

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

1 year survival rate

The percentage of participants who are alive one year after the start of the treatment.

Objective response rate (ORR)

The percentage of participants who have achieved either a complete or partial response, as assessed by Response Criteria in Solid Tumors (RECIST 1.1).

Disease control rate (DCR)

The percentage of participants who have achieved complete response, partial response and stable disease, as assessed by Response Criteria in Solid Tumors (RECIST 1.1).

Full Information

NCT ID

NCT05124002

First Posted

October 31, 2021

Last Updated

March 16, 2022

Sponsor

Beijing Tsinghua Chang Gung Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05124002

Brief Title

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

Official Title

Recombinant Human Adenovirus Type 5 Combined With Hepatic Artery Infusion Chemotherapy of FOLFOX in Patients With Intrahepatic Mass-forming Cholangiocarcinoma: a Single-site, Single-arm, Prospective Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 1, 2022 (Anticipated)

Primary Completion Date

April 1, 2024 (Anticipated)

Study Completion Date

April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Tsinghua Chang Gung Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

This is a perspective, single-arm trial. According to previous studies, the PFS of HAIC for unresectable intrahepatic cholangiocarcinoma is approximately 8 - 10 months, and one year progression free rate is about 40%. We assumed that the study could detect 20% absolute difference and 1 year PFS rate could achieve 60% PFS by (FOLFOX + H101) over conventional HAIC (FOLFOX). Simon's two-stage design is used to estimate the sample size, with α value of 0.05 and power of 0.9. A total sample size of 66 participants are required.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiocarcinoma, Intrahepatic

Keywords

oncolytic virus, intrahepatic mass-forming cholangiocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

HAIC (FOLFOX) + H101

Masking

None (Open Label)

Allocation

N/A

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

H101+HAIC

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Recombinant Human Adenovirus Type 5

Other Intervention Name(s)

H101

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

HAIC of FOLFOX

Other Intervention Name(s)

FOLFOX

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

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

Time Frame

up to 1 year

Secondary Outcome Measure Information:

Title

1 year survival rate

Description

The percentage of participants who are alive one year after the start of the treatment.

Time Frame

1 year

Title

Objective response rate (ORR)

Description

The percentage of participants who have achieved either a complete or partial response, as assessed by Response Criteria in Solid Tumors (RECIST 1.1).

Time Frame

up to 1 year

Title

Disease control rate (DCR)

Description

The percentage of participants who have achieved complete response, partial response and stable disease, as assessed by Response Criteria in Solid Tumors (RECIST 1.1).

Time Frame

up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ZHANG YUEWEI, MD

Phone

0086-13969193950

wtx419@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ZHANG YUEWEI, MD

Organizational Affiliation

Beijing Tsinghua Chang Gung Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Tsinghua Chang Gung Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

102218

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhang YUEWEI, MD

wtx419@163.com

12. IPD Sharing Statement

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

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