Head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Induction therapy stage: Iparomlimab/Tuvonralimab (QL1706) and platinum-based chemotherapy
Consolidation therapy stage: Iparomlimab/Tuvonralimab (QL1706)
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma that is not curable by local therapy; 2. Have not received any systemic therapy at the stage of recurrence or metastasis; 3. The primary tumor site was oropharynx, oral cavity, hypopharynx or larynx. Participants could not have a primary tumor site in the nasopharynx (of any histologic type). 4. At least one measurable lesion; 5. ECOG performance score of 0 or 1, with good organ function; 6. Tissue samples capable of PD-L1 biomarker analysis; 7. Test results for oropharyngeal cancer human papillomavirus (HPV) status. 8. Female participants of childbearing potential were required to have a negative pregnancy test and had to be willing to use two methods of contraception or to have been surgically sterilized or to avoid heterosexual sex during the study and for 180 days after the last dose of study drug. 9. Male participants had to agree to use an appropriate contraceptive method from the beginning of the first dose of study drug until 180 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. Diseases suitable for local treatment with curative intent. 2. Disease progression (PD) within 6 months after completion of systemic therapy for curative-intent locally advanced head and neck squamous cell carcinoma (HNSCC). 3. Received radiation therapy (or other nonsystemic therapy) within 2 weeks before enrollment or has not fully recovered from an adverse event from previous treatment. 4. Are currently participating in and receiving study treatment, or have participated in a study using a study drug or used a study device within four weeks. 5. Life expectancy less than 3 months and/or rapid disease progression. 6. Be diagnosed with immunodeficiency or receive systemic steroid therapy or any other form of immunosuppressive therapy within seven days before the first dose of study drug (physiological doses of corticosteroids may be approved after consultation with the sponsor). 7. Other malignancies were diagnosed and/or treated within 5 years before randomization, with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or cervical and/or breast cancer resected in situ. 8. Prior tissue/solid organ allograft transplantation. 9. Presence of active central nervous system metastases and/or carcinomatous meningitis. 10. Other investigators deemed ineligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival ;Overall Survival ;Adverse Events; | — |
Countries
China
Contacts
Public ContactQingwei Wang
Qilu Hospital of Shandong University
Outcome results
None listed