Sintilimab-Nimotuzumab Induction Followed by Chemoradiation-Nimotuzumab in LA-HNSCC: Single-Arm Phase II
NCT ID: NCT07310771
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
23 participants
INTERVENTIONAL
2026-01-10
2029-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sintilimab combined with chemotherapy and nimotuzumab for patients with LA-SCCHN
Sintilimab combined with chemotherapy and nimotuzumab
The study plans to enroll patients with locally advanced squamous cell carcinoma of the head and neck. After induction with sintilimab plus paclitaxel, cisplatin, and nimotuzumab, participants will receive concurrent chemoradiotherapy with nimotuzumab, followed by maintenance sintilimab monotherapy until disease progression, unacceptable toxicity, death, or withdrawal of consent.
Interventions
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Sintilimab combined with chemotherapy and nimotuzumab
The study plans to enroll patients with locally advanced squamous cell carcinoma of the head and neck. After induction with sintilimab plus paclitaxel, cisplatin, and nimotuzumab, participants will receive concurrent chemoradiotherapy with nimotuzumab, followed by maintenance sintilimab monotherapy until disease progression, unacceptable toxicity, death, or withdrawal of consent.
Eligibility Criteria
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Inclusion Criteria
2. Age 18-75 years (inclusive) at the time of informed consent; either sex.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
4. Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of the head and neck as assessed by the investigator.
5. Documented EGFR-positive tumor.
6. No prior systemic therapy for head and neck squamous cell carcinoma.
7. At least one measurable lesion per RECIST v1.1.
8. Estimated life expectancy ≥ 12 weeks.
9. Adequate bone-marrow and organ function.
Exclusion Criteria
2. Prior or concurrent malignancy (except adequately treated basal-cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma disease-free for \>5 years).
3. Uncontrolled cardiac symptoms or clinically significant cardiac disease.
4. Previous therapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or receipt of therapeutic cancer vaccines or live vaccines within 4 weeks before first study-dose administration.
5. Failure to recover to ≤ Grade 1 (per CTCAE) from prior anti-tumour therapy-except alopecia or residual neurotoxicity related to prior platinum-before first study dose.
6. Severe infection (\> CTCAE Grade 2) within 4 weeks before first study dose.
7. Active autoimmune disease or documented autoimmune-disease history requiring systemic therapy.
8. History of immunodeficiency, including positive HIV test, congenital or acquired immunodeficiency syndromes, or prior solid-organ or allogeneic bone-marrow transplantation.
9. History of interstitial lung disease or non-infectious pneumonitis.
10. Evidence of active tuberculosis infection on history or CT imaging.
11. Active hepatitis B (HBV DNA ≥ 500 IU/mL or ≥ 2,500 copies/mL).
12. History of substance abuse, alcohol abuse, or drug addiction.
13. Pregnant or lactating women.
14. Any condition that, in the investigator's opinion, could necessitate premature withdrawal from the study.
18 Years
75 Years
ALL
No
Sponsors
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Fujian Cancer Hospital
OTHER_GOV
Responsible Party
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Central Contacts
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Other Identifiers
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K2025-193-01
Identifier Type: -
Identifier Source: org_study_id