This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-ADC) in combination with Pucotenlimab(Anti-PD-1 Monoclonal Antibody) as neoadjuvant therapy for patients with Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma. The primary objective is the pathological complete response(pCR)rate following neoadjuvant therapy. The secondary objective includes the major pathological response(MPR)rate following neoadjuvant therapy, the objective response rate (ORR), Organ preservation rate, Surgery postponement rate, event-free survival (EFS), overall survival(OS), and safety.
This study is a multicenter, phase II clinical trial of neoadjuvant Becotatug Vedotin (EGFR-ADC) combined with Pucotenlimab (Anti-PD-1 monoclonal antibody) in patients with resectable locally advanced hypopharyngeal squamous cell carcinoma. Eligible participants will receive Becotatug Vedotin plus Pucotenlimab as preoperative neoadjuvant therapy, intravenous infusion every 3 weeks (Q3W) for 3 cycles.Tumor assessment will be performed after two cycles of neoadjuvant treatment. If, upon evaluation by the investigator, participants achieve a complete response (CR) based on radiographic assessment after two cycles, they may proceed directly to radical surgical resection. In the event of disease progression, severe adverse events, or intolerable toxicity during the neoadjuvant phase, the investigator may decide to discontinue neoadjuvant therapy and initiate radical therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Neoadjuvant therapy: Becotatug Vedotin is dosed based on the participant's body weight. In this study, the dosing regimen is 2.3 mg/kg, administered via intravenous infusion on Day 1 of each cycle, once every 3 weeks (Q3W), for a total of 3 treatment cycles. The infusion time for Becotatug Vedotin should be no less than 60min, and it is recommended to be controlled within 60 to 90min. Pucotenlimab is administered at a fixed dose of 200 mg per infusion, via intravenous infusion on Day 1 of each cycle, once every 3 weeks (Q3W), for a total of 3 treatment cycles, with an infusion duration of 60min (±15 min). Becotatug Vedotin and Pucotenlimab are administered on the same day, Pucotenlimab is given first, followed by Becotatug Vedotin, with an interval of no less than 30min between the two infusions.
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin 300000
Tianjin, Tianjin Municipality, China
RECRUITINGPathological Complete Response(pCR) Rate
The proportion of participants with no residual tumor cells in the resected primary tumor specimen after the completion of neoadjuvant therapy.
Time frame: At the time of surgery
Major Pathological Response(MPR) Rate
The proportion of participants who achieve a major pathological response, defined as residual viable tumor cells ≤ 10% in the resected primary tumor specimen following neoadjuvant therapy.
Time frame: At the time of surgery
Objective Response Rate(ORR)
The proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by RECIST version 1.1 after completion of neoadjuvant therapy.
Time frame: After 2 cycles or 3 cycles of neoadjuvant therapy
Event-Free Survival (EFS)
The time from the start of study treatment to the first occurrence of any of the following events, including but not limited to: disease progression precluding surgical treatment, local recurrence or distant metastasis, or death from any cause.
Time frame: From start of study treatment up to approximately 3 years
Overall Survival(OS)
The time from the start of study treatment to death from any cause.
Time frame: From start of study treatment up to approximately 5 years
Organ Preservation Rate
The proportion of participants in whom the surgical approach is optimized or the extent of surgery is reduced after neoadjuvant therapy, as determined by experienced surgeons comparing the feasible surgical approach based on baseline tumor assessment prior to neoadjuvant therapy with the feasible surgical approach after completion of neoadjuvant therapy.
Time frame: At the time of surgery
Surgery Postponement Rate
The proportion of subjects who did not undergo radical surgery within 6 weeks after the last dose of neoadjuvant therapy.
Time frame: 6 weeks after neoadjuvant therapy
Adverse Events (AEs)
Incidence, severity, and relationship to treatment of adverse events, as assessed by CTCAE criteria.
Time frame: From first dose of study treatment to 1 month after the last dose
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