Squamous Cell Carcinoma of Head and NeckPhase 2NeoCamre-HNNCT07400094
Neoadjuvant Chemoimmunotherapy (Camrelizumab + Paclitaxel + Carboplatin) for Resectable HNSCC
A Phase 2 study testing Camrelizumab, Paclitaxel and carboplatin in people with Squamous Cell Carcinoma of Head and Neck and Laryngeal Neoplasms, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.
Trial summary
This phase II study evaluates the efficacy and safety of neoadjuvant chemoimmunotherapy consisting of camrelizumab (PD-1 inhibitor), paclitaxel, and carboplatin in patients with resectable locally advanced (Stage III-IVA) squamous cell carcinoma of the oral cavity and/or larynx. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck, Laryngeal Neoplasms, Oral Cavity Neoplasm
- What is being tested?
- Camrelizumab, Paclitaxel and carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2026to Feb 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
- Histologically confirmed squamous cell carcinoma of the oral cavity and/or larynx, Stage III-IVA (cT1-2N1-2M0, cT3-4aN0-2M0)
- Resectable disease planned for surgical treatment
- Age 18-75 years
- No prior antitumor therapy for the current diagnosis
- Tumor sample available for PD-L1 expression assessment
- No other malignancies in anamnesis (except basal cell carcinoma of skin and carcinoma in situ of cervix)
- Absence of comorbidities preventing systemic chemotherapy and immunotherapy
Who cannot join
- Patient refusal to undergo planned treatment
- Protocol violations not related to medical indications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
P.A. Hertsen Moscow Oncology Research Institute
Moscow
Larisa V. Bolotina, MD, PhD, +79039686637, lbolotina@yandex.ru
Maxim S. Ruban, MD, +79204335470, ruban.m.s@yandex.ru
About this study
Official title: Prospective Non-Randomized Phase II Study of Neoadjuvant Camrelizumab Combined With Paclitaxel and Carboplatin in Patients With Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity and Larynx (Stage III-IVA)
This phase II study evaluates the efficacy and safety of neoadjuvant chemoimmunotherapy consisting of camrelizumab (PD-1 inhibitor), paclitaxel, and carboplatin in patients with resectable locally advanced (Stage III-IVA) squamous cell carcinoma of the oral cavity and/or larynx.
Fifty patients will receive 3 cycles of therapy (camrelizumab 200 mg IV, paclitaxel 175 mg/m2 IV, carboplatin AUC6 IV, Day 1 every 21 days) followed by radical surgery 4-6 weeks later. Patients are then stratified to risk-adapted adjuvant therapy based on pathological findings (radiation or chemoradiation with cisplatin if adverse features present).
Read more
The primary endpoint is the pathological complete response (pCR) rate and major pathological response (MPR, <10% viable tumor cells) rate at surgery. Secondary endpoints include objective response rate (ORR) by imaging (MRI/PET-CT), correlation of PET-CT metabolic response with pathological response, proportion requiring adjuvant chemoradiation, and 3-year event-free survival compared to historical controls.
Study period: 2026-2029.
Read the detailed description
Investigator-initiated, single-arm, phase II study conducted at P.A. Hertsen Moscow Oncology Research Institute. Protocol approved by Local Ethics Committee (#1187/132).
- Being tested
- Camrelizumab, Paclitaxel, carboplatin, Radical Surgery
- Keywords
- Head and Neck Squamous Cell Carcinoma, Neoadjuvant Therapy, Camrelizumab, Paclitaxel, Carboplatin, Pathological Complete Response, PD-1 Inhibitor
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Laryngeal Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Also called SHR-1210
200 mg IV on Day 1, every 21 days for 3 cycles
PaclitaxelDrug
Also called Taxol
175 mg/m² IV on Day 1, every 21 days for 3 cycles
carboplatinDrug
Also called Paraplatin
AUC 6 IV on Day 1, every 21 days for 3 cycles
Radical SurgeryProcedure or surgery
Standard radical resection 4-6 weeks after neoadjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemoimmunotherapy | Experimental | Patients receive 3 cycles of camrelizumab + paclitaxel + carboplatin followed by surgery.
Number of Participants: 50 (Anticipated) Receives: Drug: Camrelizumab; Drug: Paclitaxel; Drug: carboplatin; Procedure: Radical Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
Rate of complete pathological response (absence of viable tumor cells in resected specimen)
Measured: At the time of surgery (approximately 10-12 weeks from baseline)
Major Pathological Response (MPR) Rate
Rate of major pathological response (<10% viable tumor cells in resected specimen)
Measured: At the time of surgery (approximately 10-12 weeks from baseline)
Secondary outcomes (4)
Objective Response Rate (ORR)
Rate of objective response by imaging (MRI/PET-CT) compared to historical TPF control
Measured: After 3 cycles of neoadjuvant therapy (approximately 9 weeks)
3-Year Event-Free Survival (EFS)
EFS compared to historical control (surgery + RT/CRT)
Measured: 3 years from enrollment
Incidence of Adverse Events
Safety profile compared to standard TPF induction chemotherapy
Measured: From first dose until 30 days after surgery
Proportion Requiring Adjuvant Chemoradiation
Patients needing post-op CRT due to adverse pathological features vs historical control
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larisa V. Bolotina, MD, PhD, Study chair, P.A. Hertsen Moscow Oncology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400094
- Sponsor's protocol ID
- NeoCamre-HN-01
- Other IDs
- LEC #1187/132
- Acronym
- NeoCamre-HN
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an investigator-initiated, single-center study conducted in Russia. Individual participant data will not be shared due to patient confidentiality requirements and institutional data protection policies.
Publications
Wu D, Li Y, Xu P, Fang Q, Cao F, Lin H, Li Y, Su Y, Lu L, Chen L, Li Y, Zhao Z, Hong X, Li G, Tian Y, Sun J, Yan H, Fan Y, Zhang X, Li Z, Liu X. Neoadjuvant chemo-immunotherapy with camrelizumab plus nab-paclitaxel and cisplatin in resectable locally advanced squamous cell carcinoma of the head and neck: a pilot phase II trial. Nat Commun. 2024 Mar 11;15(1):2177. doi: 10.1038/s41467-024-46444-z.
PubMed 38467604
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-Randomized Phase II Study of Neoadjuvant Camrelizumab Combined With Paclitaxel and Carboplatin in Patients With Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity and Larynx (Stage III-IVA)
- ClinicalTrials.gov ID
- NCT07400094
- Acronym / sponsor ID
- NeoCamre-HN / NeoCamre-HN-01
- Keywords
- Head and Neck Squamous Cell Carcinoma, Neoadjuvant Therapy, Camrelizumab, Paclitaxel, Carboplatin, Pathological Complete Response, PD-1 Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Medical Research Radiological Centre of the Ministry of Health of RussiaUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 10 Feb 2026 (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 phase II study evaluates the efficacy and safety of neoadjuvant chemoimmunotherapy consisting of camrelizumab (PD-1 inhibitor), paclitaxel, and carboplatin in patients with resectable locally advanced (Stage III-IVA) squamous cell carcinoma of the oral cavity and/or larynx.
Fifty patients will receive 3 cycles of therapy (camrelizumab 200 mg IV, paclitaxel 175 mg/m2 IV, carboplatin AUC6 IV, Day 1 every 21 days) followed by radical surgery 4-6 weeks later. Patients are then stratified to risk-adapted adjuvant therapy based on pathological findings (radiation or chemoradiation with cisplatin if adverse features present).
The primary endpoint is the pathological complete response (pCR) rate and major pathological response (MPR, <10% viable tumor cells) rate at surgery. Secondary endpoints include objective response rate (ORR) by imaging (MRI/PET-CT), correlation of PET-CT metabolic response with pathological response, proportion requiring adjuvant chemoradiation, and 3-year event-free survival compared to historical controls.
Study period: 2026-2029.
Detailed description
Investigator-initiated, single-arm, phase II study conducted at P.A. Hertsen Moscow Oncology Research Institute. Protocol approved by Local Ethics Committee (#1187/132).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemoimmunotherapy | Experimental | Drug: Camrelizumab, Drug: Paclitaxel, Drug: carboplatin, Procedure: Radical SurgeryPatients receive 3 cycles of camrelizumab + paclitaxel + carboplatin followed by surgery. Number of Participants: 50 (Anticipated) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed squamous cell carcinoma of the oral cavity and/or larynx, Stage III-IVA (cT1-2N1-2M0, cT3-4aN0-2M0)
- Resectable disease planned for surgical treatment
- Age 18-75 years
- No prior antitumor therapy for the current diagnosis
- Tumor sample available for PD-L1 expression assessment
Key exclusion criteria (2 listed)
- Patient refusal to undergo planned treatment
- Protocol violations not related to medical indications
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 |
|---|---|---|
| CamrelizumabAlso: SHR-1210200 mg IV on Day 1, every 21 days for 3 cycles | Drug | Neoadjuvant Chemoimmunotherapy |
| PaclitaxelAlso: Taxol175 mg/m² IV on Day 1, every 21 days for 3 cycles | Drug | Neoadjuvant Chemoimmunotherapy |
| carboplatinAlso: ParaplatinAUC 6 IV on Day 1, every 21 days for 3 cycles | Drug | Neoadjuvant Chemoimmunotherapy |
| Radical SurgeryStandard radical resection 4-6 weeks after neoadjuvant therapy | Procedure or surgery | Neoadjuvant Chemoimmunotherapy |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: At the time of surgery (approximately 10-12 weeks from baseline)
Rate of complete pathological response (absence of viable tumor cells in resected specimen)
Major Pathological Response (MPR) Rate
Time frame: At the time of surgery (approximately 10-12 weeks from baseline)
Rate of major pathological response (<10% viable tumor cells in resected specimen)
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: After 3 cycles of neoadjuvant therapy (approximately 9 weeks)
3-Year Event-Free Survival (EFS)
Time frame: 3 years from enrollment
Incidence of Adverse Events
Time frame: From first dose until 30 days after surgery
Proportion Requiring Adjuvant Chemoradiation
Time frame: At the time of surgery
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 10 Feb 2026.
- Background: PubMed 38467604Wu D, Li Y, Xu P, Fang Q, Cao F, Lin H, Li Y, Su Y, Lu L, Chen L, Li Y, Zhao Z, Hong X, Li G, Tian Y, Sun J, Yan H, Fan Y, Zhang X, Li Z, Liu X. Neoadjuvant chemo-immunotherapy with camrelizumab plus nab-paclitaxel and cisplatin in resectable locally advanced squamous cell carcinoma of the head and neck: a pilot phase II trial. Nat Commun. 2024 Mar 11;15(1):2177. doi: 10.1038/s41467-024-46444-z.
- Individual participant dataSharing planned: No. This is an investigator-initiated, single-center study conducted in Russia. Individual participant data will not be shared due to patient confidentiality requirements and institutional data protection policies.
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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.
Larisa V. Bolotina, MD, PhD study chair
P.A. Hertsen Moscow Oncology Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab, Paclitaxel and carboplatin in people with Squamous Cell Carcinoma of Head and Neck and Laryngeal Neoplasms, run by National Medical Research Radiological Centre of the Ministry of Health of Russia at 1 site in Russia.
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 7 inclusion and 2 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: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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 Larisa V. Bolotina, MD, PhD (+79039686637, lbolotina@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: At the time of surgery (approximately 10-12 weeks from baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07400094, which also lists 1 linked publication.
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 10 Feb 2026.