The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of Becotatug Vedotin with Pucotenlimab as a possible neoadjuvant therapyand for locally advanced oral/pharyngeal squamous cell carcinoma.
Approximately 60% of patients with oral/oropharyngeal squamous cell carcinoma (OSCC) are found to be in the local advanced stage. Even if they actively undergo comprehensive sequential treatment such as surgery, radiotherapy, and chemotherapy, the 5-year survival rate is still less than 50%. According to both the NCCN and the CSCO head and neck cancer treatment guidelines, radical surgery is the main treatment strategy for locally advanced OSCC, and adjuvant radiotherapy or chemotherapy/radiotherapy. However, the high treatment failure rate and disease recurrence rate are still the fundamental reasons for its poor prognosis. In recent years, neoadjuvant therapy has been proven to reduce the burden of local diseases in multiple tumor types, thereby improving surgical outcomes, reducing the risk of distant metastasis, and predicting prognosis based on the patient's pathological response. The combination of anti-PD-1/PD-L1 monoclonal antibodies and EGFR ADC drugs has a synergistic anti-tumor effect, and this combination therapy is worth exploring in the neoadjuvant treatment of locally advanced oral/oropharyngeal squamous cell carcinoma. This prospective, open label, single arm, phase II, single center exploratory study aims to evaluate the efficacy and safety of the combination therapy of Becotatug Vedotin and Pucotenlimab as neoadjuvant therapy in patients with locally advanced oral/oropharyngeal squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
The participants will receive Pucotenlimab 200 mg (each 3-week/cycle) and Becotatug Vedotin (2.3mg/kg, each 3-week/cycle) for 2 cycles bofore surgery
Rate of Major Pathological Response (mPR)
Major pathologic response (mPR) is defined as having ≤ 10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced mPR
Time frame: 2 months
Rate of Pathologic complete response (pCR)
Pathologic complete response (PCR) is defined as having no invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced PCR.
Time frame: 2 months
1 year Event-free Survival (EFS) Rate
EFS is the time from the date of study entry to the date of first record of disease progression as defined by RECIST 1.1
Time frame: 12 months
1 year Overall Survival (OS) Rate
OS is the time from study entry to death due to any cause
Time frame: 12 months
2 year Event-free Survival (EFS) Rate
Time frame: 24 months
2 year Overall Survival (OS) Rate
Time frame: 24 months
Adverse Events (AEs)
Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions
Time frame: 24 months
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