Chemotherapy plus finotonlimab before main treatment for locally advanced hypopharyngeal cancer
Official title: Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study
Run by Eye & ENT Hospital of Fudan University · NCT07248956 · Data updated 2026-11-12
This tries giving finotonlimab (a PD‑1 drug) together with chemotherapy before definitive treatment for adults with resectable stage III–IVA hypopharyngeal cancer who have at least a 50% tumor shrinkage.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 116 (estimated) |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Drugs / interventions | sintilimab, chemotherapy, immunotherapy |
| Locations | 7 sites (Harbin, Heilongjiang and 6 other locations) |
| Status | Recruiting |
| Started | December 22, 2025 |
| Main results expected | November 30, 2027 |
| Study ends | December 30, 2029 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07248956 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 who are treatment‑naïve with resectable stage III–IVA hypopharyngeal carcinoma, ECOG 0–2, and who achieve at least a 50% tumor reduction after the neoadjuvant regimen.
✕Probably not a fit
Patients who are pregnant or breastfeeding, have active autoimmune disease, poorly controlled cardiac or other major illnesses, other concurrent malignancies, hypersensitivity to the study drugs, or who do not reach the required ≥50% response after neoadjuvant therapy are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized, prospective Phase 2 study of neoadjuvant chemotherapy combined with the PD‑1 inhibitor finotonlimab in locally advanced hypopharyngeal carcinoma. Patients receive induction nab‑paclitaxel and cisplatin together with finotonlimab, and those who achieve a major partial response (≥50% by RECIST 1.1) are then assigned to different subsequent definitive treatment options. The trial compares safety and effectiveness of those subsequent options, which may include definitive radiotherapy or surgery followed by postoperative radiotherapy or chemoradiotherapy. The primary focus is on tumor response, treatment safety, and the feasibility of organ‑preserving approaches in responders.
Why it matters
Potential benefit: If successful, the approach could increase tumor shrinkage before definitive therapy and enable less extensive surgery or more organ‑preserving radiotherapy.
How similar studies have gone: Combining PD‑1 inhibitors with induction chemotherapy has shown promise in other head and neck cancers, but large‑scale and disease‑specific data for locally advanced hypopharyngeal carcinoma are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Willingness to provide written informed consent; 2. Age ≥18 and ≤75 years; 3. Treatment-naïve for malignant disease; 4. Resectable stage III-IVA hypopharyngeal carcinoma with response of PR ≥ 50% after neoadjuvant therapy according to RECIST 1.1 ; 5. ECOG performance status 0-2. Exclusion Criteria: 1. Pregnancy or breastfeeding status; 2. Hypersensitivity to sintilimab, nab-paclitaxel, or their formulation components; 3. Poorly controlled cardiovascular conditions or other diseases; 4. Active or documented history of autoimmune diseases requiring systemic treatment; 5. Synchronous or metachronous malignancies; 6. Other conditions deemed ineligible for the study by investigators.
Where it's running
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Eye & ENT Hospital, Fudan University
Shanghai, China Recruiting -
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China Not yet recruiting -
Shandong Provincial ENT Hospital
Jinan, Shandong, China Not yet recruiting -
Beijing Tongren Hospital, Capital Medical University
Beijing, China Not yet recruiting -
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China Not yet recruiting -
Zhongshan Hospital of Fudan University
Shanghai, China Not yet recruiting
Show 1 more location
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, China Not yet recruiting
Study contacts
- Principal investigator: Ming Zhang, PhD — Eye & ENT Hospital, Fudan University
- Study coordinator: Chiyao Hsueh
- Email: hsuehchiyao@gmail.com
- Phone: 021-64377134
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.