A Phase II Study of Neoadjuvant Immunotherapy in Combination With Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

ConditionHead and Neck Squamous Cell Carcinoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorLei Liu

About this trial

A Randomized, Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection.

This proposed study will evaluate the efficacy and safety of preoperative administration of ivonescimab or cadonilimab or penpulimab combined with chemotherapy in HNSCC who are eligible for resection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females； Age：18 to 75 years.

Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC).

Patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Disqualifiers

Patients who have received any form of anti-tumor treatment previously.

Patients with allergic constitution and congenital immune deficiencies.

Patients who have undergone organ transplantation.

Patients with a history of severe bleeding tendencies or coagulation dysfunction; those who have had clinically significant bleeding symptoms within 1 month prior to the study treatment, including but not limited to gastrointestinal bleeding, hemoptysis; those who have received prolonged anticoagulation treatment within 10 days prior to the study treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

Ivonescimab combined with TP
Drug
Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
Cadonilimab combined with TP
Drug
Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.
Penpulimab combined with TP
Drug
Both interventions all drugs intravenous infusion, D1, once every 3 weeks, a total of 3 cycles.

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Ivonescimab in combination with Nab-paclitaxel + CisplatinExperimental treatment 1 intervention

Group B: Cadonilimab in combination with Nab-paclitaxel + CisplatinExperimental treatment 1 intervention

Group C: Penpulimab in combination with Nab-paclitaxel + CisplatinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

pCR

Pathological complete response rate

Time frame

After surgery (approximately 9-10 weeks after start of study treatment)

Secondary outcomes

MPR

major pathological remission

Time frame

After surgery (approximately 9-10 weeks after start of study treatment)

Other outcomes

ORR

objective response rate

Time frame

9-10 weeks

EFS

event free survival

Time frame

1 years

overall survival

Time frame

2 years

Sponsors and contacts

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

Lei Liu

Lead sponsor

West China Hospital

Sponsor institution

Source ClinicalTrials.gov

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