Chemotherapy plus finotonlimab before main treatment for locally advanced hypopharyngeal cancer

Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study

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
• Enrollment: 116 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (Academic / other)
• Drugs / interventions: sintilimab, chemotherapy, immunotherapy
• Locations: 7 sites (Harbin, Heilongjiang and 6 other locations)
• Trial ID: NCT07248956 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Harbin, Heilongjiang and 6 other locations

• 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)
• Eye & ENT Hospital, Fudan University — Shanghai, China (Recruiting)
• Zhongshan Hospital of Fudan University — Shanghai, China (Not_yet_recruiting)
• 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

Conditions Hypopharyngeal Carcinoma; PD-1 inhibitor; neoadjuvant therapy; locally advanced