H101 Plus TACE for r/m HNSCC

NCT07398664 | Not Yet Recruiting Phase 2

• 1 other identifier: WCH2025-ONCO-1179
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates H101 combined with transarterial chemoembolization (TACE) to enhance local tumor killing and immune activation while minimizing toxicity in r/m HNSCC patients.

Conditions

Head and Neck Squamous Cell Carcinoma; Oncolytic Virus; TACE

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The proportion of participants achieving a complete response (CR) or partial response (PR) based on modified RECIST v1.1 (mRECIST) criteria for target lesions assessed via MRI or CT imaging.

  Tumor assessments performed at baseline, then every 6-12 weeks from the start of treatment until disease progression or study completion (up to 24 months).

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  From the start of treatment until the first documented progression or death from any cause (assessed up to 24 months).

• Overall Survival (OS)

  From the start of treatment until death from any cause (assessed up to 24 months).

• Incidence of Treatment-Related Adverse Events (AEs)

  From the first administration of H101/TACE until 60 days after the last administration.

Other Outcomes (2)

• Change in Quality of Life (QoL) Score

  Assessed at baseline, then every 4-8 weeks from the start of treatment until disease progression or study completion (up to 24 months).

• Change in Head and Neck Cancer-Specific Symptoms

  Assessed at baseline, then every 4-8 weeks from the start of treatment until disease progression or study completion (up to 24 months).

Study Arms (1)

H101+TACE

EXPERIMENTAL

Drug: H101; Procedure: TACE

Interventions

H101 DRUG

H101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC)

H101+TACE

TACE PROCEDURE

H101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC)

H101+TACE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and under 80 years old.
• Pathologically confirmed head and neck malignancies (including nasopharyngeal carcinoma, oral cavity cancer, oropharyngeal cancer, laryngeal cancer, hypopharyngeal cancer, salivary gland cancer, nasal cavity and paranasal sinus cancer, etc.); patients who have failed at least two lines of standard treatment (including cetuximab and immuno check point inhibitors).
• Expected survival ≥3 months.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.
• Pre-treatment peripheral blood tests meet the following conditions: neutrophil count \>2000/mm³, platelet count \>100,000/mm³.
• Pre-treatment liver and kidney function meet the following: bilirubin \<1.5 mg/dL, AST or ALT \<1.5 times the upper limit of normal, serum creatinine \<1.5 mg/dL, creatinine clearance \>60 mL/min.
• Agreement to follow the trial treatment plan and visit schedule, voluntary participation, and written informed consent.

You may not qualify if:

• Expected survival less than 3 months.
• Positive pregnancy test for women of childbearing age.
• Concurrent diseases or conditions that affect the patient's ability to enroll normally or safety during the study period.
• Active psychiatric disorders or other psychological conditions that affect the patient's ability to sign the informed consent or understand the study.
• Severe coagulation abnormalities and/or active infection requiring intravenous anti-infective therapy.
• History of another malignancy within 5 years prior to screening, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or microscopic papillary thyroid carcinoma that have been treated with potential curative therapy.
• Severe cardiac arrhythmia or conduction abnormalities, and clinically uncontrolled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>90 mmHg).
• Adverse reactions from prior anti-tumor treatments have not recovered to CTCAE version 5.0 Grade \<1 (except for toxicities judged by the investigator to pose no safety risk, such as alopecia, Grade 2 peripheral neuropathy, etc.).
• History of infectious diseases, such as positive HIV antibody test, active hepatitis B (defined as HBsAg positive during screening, with HBV-DNA levels above the upper limit of normal at the local laboratory), or hepatitis C (defined as positive HCV-Ab test during screening with positive HCV-RNA).
• Other conditions considered by the investigator to potentially affect patient compliance or make the patient unsuitable for participation in this study.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Tao Hai

CONTACT

086-18982770417; haitao42@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 10, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02