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A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

ConditionHead and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWest China Hospital

About this trial

A Randomized, Non-comparative Phase II Clinical Trial of Becotatug Vedotin Combined with or without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LAHNSCC). This proposed study will evaluate the efficacy and safety of preoperative administration of Becotatug Vedotin Combined with or without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in LAHNSCC who are eligible for resection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 - 70 years old, gender not restricted;

Histopathologically diagnosed as squamous cell carcinoma of the head and neck (including oral cancer, laryngeal cancer, hypopharyngeal cancer, and oropharyngeal cancer, etc.);

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

Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;

Disqualifiers

Has received any form of anti-tumor treatment before;

Patients with allergic constitution and congenital immune deficiency;

Has undergone organ transplantation before;

Has a history of severe bleeding tendency or coagulation dysfunction; had significant clinical bleeding symptoms within 1 month before the study treatment, including but not limited to gastrointestinal bleeding and hemoptysis; had continuous anticoagulation treatment within 10 days before the study treatment;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Becotatug Vedotin

    Drug

    Subjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1).

  • Becotatug Vedotin Combined with Penpulimab

    Drug

    Subjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Penpulimab (200mg, ivgtt, every 3 weeks, D1).

  • Becotatug Vedotin Combined with Ivonescimab

    Drug

    Subjects received 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Ivonescimab (10mg/kg, ivgtt, every 3 weeks, D1).

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Becotatug VedotinExperimental treatment 1 intervention
Group B: Becotatug Vedotin Combined with PenpulimabExperimental treatment 1 intervention
Group C: Becotatug Vedotin Combined with IvonescimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pCR

Pathological complete response rate

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

Secondary outcomes

1

MPR

major pathological remission

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

Other outcomes

1

ORR

objective response rate

Time frame
9-10 weeks
2

EFS

event free survival

Time frame
1 years
3

OS

overall survival

Time frame
2 years

Sponsors and contacts

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

West China Hospital

Lead sponsor

Source ClinicalTrials.gov
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