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Neoadjuvant Chemoimmunotherapy (Camrelizumab + Paclitaxel + Carboplatin) for Resectable HNSCC

ConditionsSquamous Cell Carcinoma of Head and NeckLaryngeal NeoplasmsOral Cavity Neoplasm
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNational Medical Research Radiological Centre of the Ministry of Health of Russia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient refusal to undergo planned treatment

Protocol violations not related to medical indications

Trial design

Design model

Single group

Treatments tested in this trial

  • Camrelizumab

    Drug

    200 mg IV on Day 1, every 21 days for 3 cycles

  • Paclitaxel

    Drug

    175 mg/m² IV on Day 1, every 21 days for 3 cycles

  • carboplatin

    Drug

    AUC 6 IV on Day 1, every 21 days for 3 cycles

  • Radical Surgery

    Procedure/Surgery

    Standard radical resection 4-6 weeks after neoadjuvant therapy

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Neoadjuvant ChemoimmunotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pathological Complete Response (pCR) Rate

Rate of complete pathological response (absence of viable tumor cells in resected specimen)

Time frame
At the time of surgery (approximately 10-12 weeks from baseline)
2

Major Pathological Response (MPR) Rate

Rate of major pathological response (\<10% viable tumor cells in resected specimen)

Time frame
At the time of surgery (approximately 10-12 weeks from baseline)

Secondary outcomes

1

Objective Response Rate (ORR)

Rate of objective response by imaging (MRI/PET-CT) compared to historical TPF control

Time frame
After 3 cycles of neoadjuvant therapy (approximately 9 weeks)
2

3-Year Event-Free Survival (EFS)

EFS compared to historical control (surgery + RT/CRT)

Time frame
3 years from enrollment
3

Incidence of Adverse Events

Safety profile compared to standard TPF induction chemotherapy

Time frame
From first dose until 30 days after surgery
4

Proportion Requiring Adjuvant Chemoradiation

Patients needing post-op CRT due to adverse pathological features vs historical control

Time frame
At the time of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Medical Research Radiological Centre of the Ministry of Health of Russia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: