Hypopharyngeal CarcinomaPhase 2NCT07248956
Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma
A Phase 2 study testing Finolizumab, Albumin-Bound Paclitaxel /nab-Paclitaxel and Cisplatin in people with Hypopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University at 7 sites in China.
Trial summary
This is a multi-center, randomized controlled, prospective clinical study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypopharyngeal Carcinoma
- What is being tested?
- Finolizumab, Albumin-Bound Paclitaxel /nab-Paclitaxel and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 7 sitesChina
- Study dates
- 22 Dec 2025to 30 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to provide written informed consent;
- Age ≥18 and ≤75 years;
- Treatment-naïve for malignant disease;
- Resectable stage III-IVA hypopharyngeal carcinoma with response of PR ≥ 50% after neoadjuvant therapy according to RECIST 1.1 ;
- ECOG performance status 0-2.
Who cannot join
- Pregnancy or breastfeeding status;
- Hypersensitivity to sintilimab, nab-paclitaxel, or their formulation components;
- Poorly controlled cardiovascular conditions or other diseases;
- Active or documented history of autoimmune diseases requiring systemic treatment;
- Synchronous or metachronous malignancies;
- Other conditions deemed ineligible for the study by investigators.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing
Qi Zhong, PhD, 8613520298736, zhongqi_ent@126.com
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Changming An, PhD, 8613811381160, mran1979@163.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Susheng Miao, PhD, 8613796620079, drmiaosusheng@126.com
- Not yet recruiting
Shandong Provincial ENT Hospital
Jinan, Shandong
Zhenghua Lv, PhD, 8615168889970, entlvzhenghua@163.com
- Recruiting
Eye & ENT Hospital, Fudan University
Shanghai
Ming Zhang, PhD, 8621-64377151, zmzlm@163.com
- Not yet recruiting
Zhongshan Hospital of Fudan University
Shanghai
Xinsheng Huang, PhD, 8613681791739, huang.xinsheng@zs-hospital.sh.cn
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Xuan Zhou, PhD, 8618622682591, xuanzhou@tmu.edu.cn
About this study
Official title: Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study
This is a multi-center, randomized controlled, prospective clinical study.
Read the detailed description
The early symptoms of hypopharyngeal cancer are often inconspicuous, with approximately 70% of patients clinically diagnosed at an advanced stage. With the emergence of immunotherapy, immune therapies such as PD-1 inhibitors combined with induction chemotherapy have been widely explored in various tumor types. Currently, there is a lack of large-scale real-world studies on the efficacy and safety of treatment options for patients with locally advanced hypopharyngeal cancer who respond well to neoadjuvant therapy. This study aims to employ neoadjuvant chemotherapy combined with immunotherapy for locally advanced hypopharyngeal cancer and explore the effectiveness and safety of different subsequent treatment options for patients assessed as achieving a major partial response (PR ≥50%).
- Conditions
- Hypopharyngeal Carcinoma
- Being tested
- Finolizumab, Albumin-Bound Paclitaxel /nab-Paclitaxel, Cisplatin, Definitive radiotherapy, Surgery with postoperative radiotherapy or chemoradiotherapy.
- Keywords
- PD-1 inhibitor, neoadjuvant therapy, locally advanced
- Medical subject headings
- Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinolizumabDrug
200mg every 3 weeks (q3w) for 2 cycles.
Albumin-Bound Paclitaxel /nab-PaclitaxelDrug
260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.
CisplatinDrug
25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.
Definitive radiotherapyRadiation
Definitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks)
Surgery with postoperative radiotherapy or chemoradiotherapy.Procedure or surgery
surgery with postoperative radiotherapy or chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant therapy followed by surgery and (C)RT group | Experimental | Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive surgery, followed by postoperative radiotherapy or chemoradiotherapy. Receives: Drug: Finolizumab; Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel; Drug: Cisplatin; Procedure: Surgery with postoperative radiotherapy or chemoradiotherapy. |
| neoadjuvant therapy followed by CCRT group | Active comparator | Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive definitive radiotherapy with concurrent cisplatin-based chemotherapy. Receives: Drug: Finolizumab; Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel; Drug: Cisplatin; Radiation: Definitive radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
Duration from treatment initiation until the first occurrence of any of the following events: disease progression precluding surgical intervention, local or distant recurrence, death from any cause, etc.
Measured: 2 years
Secondary outcomes (5)
Overall Survival (OS)
Duration from the date of tumor treatment initiation to the date of first documented death from any cause or the last follow-up date.
Measured: 2 years
Locoregional Control Rate (LRFS)
Duration from the date of tumor treatment initiation to the date of first documented locoregional recurrence, death from any cause, or the last follow-up date.
Measured: 2 years
Laryngeal Preservation Rate
The proportion of patients who successfully retain laryngx function after treatment.
Measured: 2 years
Major Pathological Response Rate (MPR)
The presence of ≤10% viable invasive squamous cell carcinoma in the resected primary tumor and neck lymph nodes.
Measured: 2 years
Adverse events
Acute treatment-related toxicities were evaluated using CTCAE v5.0 (Common Terminology Criteria for Adverse Events, Version 5.0), with patient counts reported for each AE category.
Late radiation toxicities were assessed per the RTOG (Radiation Therapy Oncology Group) grading criteria, with both patient numbers and incidence rates documented.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start22 Dec 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Zhang, Eye & ENT Hospital of Fudan University
- Investigators
- Ming Zhang, PhD, Principal investigator, Eye & ENT Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248956
- Sponsor's protocol ID
- SOAR-HP
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07248956
- Acronym / sponsor ID
- SOAR-HP
- Conditions
- Hypopharyngeal Carcinoma
- Keywords
- PD-1 inhibitor, neoadjuvant therapy, locally advanced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, randomized controlled, prospective clinical study.
Detailed description
The early symptoms of hypopharyngeal cancer are often inconspicuous, with approximately 70% of patients clinically diagnosed at an advanced stage. With the emergence of immunotherapy, immune therapies such as PD-1 inhibitors combined with induction chemotherapy have been widely explored in various tumor types. Currently, there is a lack of large-scale real-world studies on the efficacy and safety of treatment options for patients with locally advanced hypopharyngeal cancer who respond well to neoadjuvant therapy. This study aims to employ neoadjuvant chemotherapy combined with immunotherapy for locally advanced hypopharyngeal cancer and explore the effectiveness and safety of different subsequent treatment options for patients assessed as achieving a major partial response (PR ≥50%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant therapy followed by surgery and (C)RT group | Experimental | Drug: Finolizumab, Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel, Drug: Cisplatin, Procedure: Surgery with postoperative radiotherapy or chemoradiotherapy.Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive surgery, followed by postoperative radiotherapy or chemoradiotherapy. |
| neoadjuvant therapy followed by CCRT group | Active comparator | Drug: Finolizumab, Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel, Drug: Cisplatin, Radiation: Definitive radiotherapyPatients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive definitive radiotherapy with concurrent cisplatin-based chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willingness to provide written informed consent;
- Age ≥18 and ≤75 years;
- Treatment-naïve for malignant disease;
- Resectable stage III-IVA hypopharyngeal carcinoma with response of PR ≥ 50% after neoadjuvant therapy according to RECIST 1.1 ;
- ECOG performance status 0-2.
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding status;
- Hypersensitivity to sintilimab, nab-paclitaxel, or their formulation components;
- Poorly controlled cardiovascular conditions or other diseases;
- Active or documented history of autoimmune diseases requiring systemic treatment;
- Synchronous or metachronous malignancies;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finolizumab200mg every 3 weeks (q3w) for 2 cycles. | Drug | neoadjuvant therapy followed by CCRT group, neoadjuvant therapy followed by surgery and (C)RT group |
| Albumin-Bound Paclitaxel /nab-Paclitaxel260mg/m², day 1, every 3 weeks (q3w) for 2 cycles. | Drug | neoadjuvant therapy followed by CCRT group, neoadjuvant therapy followed by surgery and (C)RT group |
| Cisplatin25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles. | Drug | neoadjuvant therapy followed by CCRT group, neoadjuvant therapy followed by surgery and (C)RT group |
| Definitive radiotherapyDefinitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks) | Radiation | neoadjuvant therapy followed by CCRT group |
| Surgery with postoperative radiotherapy or chemoradiotherapy.surgery with postoperative radiotherapy or chemoradiotherapy. | Procedure or surgery | neoadjuvant therapy followed by surgery and (C)RT group |
Primary outcome
Event-free survival (EFS)
Time frame: 2 years
Duration from treatment initiation until the first occurrence of any of the following events: disease progression precluding surgical intervention, local or distant recurrence, death from any cause, etc.
5 secondary outcomes
Overall Survival (OS)
Time frame: 2 years
Locoregional Control Rate (LRFS)
Time frame: 2 years
Laryngeal Preservation Rate
Time frame: 2 years
Major Pathological Response Rate (MPR)
Time frame: 2 years
Adverse events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming Zhang, PhD principal investigator
Eye & ENT Hospital, Fudan University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Finolizumab, Albumin-Bound Paclitaxel /nab-Paclitaxel and Cisplatin in people with Hypopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiyao Hsueh (021-64377134, hsuehchiyao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.