A multicenter, randomized, double-blind, phase II clinical study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of Becotatug Vedotin for Injection in combination with PD-1 in patients with locally advanced resectable head and neck squamous cell carcinoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Fujian Medical University
Major Pathological Response (MPR) Rate
Time frame: From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
Pathological Complete Response (pCR) Rate
Time frame: From date of surgery until completion of postoperative pathological assessment, up to 8 weeks
Event-Free Survival (EFS)
Time frame: From date of randomization until the date of disease progression/recurrence with initiation of new anti-tumor therapy, or death from any cause, whichever came first, assessed up to 24 months
Overall Survival (OS)
Time frame: From date of randomization until death from any cause, assessed up to 36 months
Preoperative Objective Response Rate (ORR)
Time frame: preoperative ORR will be assessed up to 12 weeks post-randomization
actual surgical resection rate
Time frame: surgical resection rate will be evaluated perioperatively
R0 resection rate
Time frame: R0 resection rate will be confirmed up to 8 weeks postoperatively
lymph node downstaging rate
Time frame: lymph node downstaging rate will be determined up to 8 weeks postoperatively based on comparison of pre- and post-treatment imaging and pathology
Incidence of adverse events (AEs) and laboratory abnormalities assessed by CTCAE v6.0
Time frame: Within 30 days after last dose (30 days + 7 days window)
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Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGCancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
NOT_YET_RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGThe Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGHubei Cancer Hospital
Wuhan, Hubei, China
NOT_YET_RECRUITINGXiangya Hospital of Central South University
Changsha, Hunan, China
NOT_YET_RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
NOT_YET_RECRUITING...and 5 more locations
Serum Concentration
Time frame: From randomization through completion of therapy, up to 30 weeks
Incidence of Anti-Drug Antibodies (ADA)
Time frame: From randomization through completion of therapy, up to 30 weeks