Neoadjuvant Personalized Anti-PD-1 Therapy With Combination of Anti-VEGFR Therapy in Locally Advanced and Resectable Oral Squamous Cell Carcinoma: A Randomized Controlled Phase II Trial
Who is this study for? Patients with Oral Squamous Cell Carcinoma
What treatments are being studied? Camrelizumab (Anti-PD-1 Inhibitor)+Apatinib (Anti-VEGFR Inhibitor)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To evaluate the efficacy of neoadjuvant anti-PD-1 plus anti-VEGFR therapy for patients with locally advanced and resectable oral squamous cell carcinoma, and the CPS\>10 in the biopsy samples.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age: 18 to 75
• Gender: Male and female
• ECOG Score: 0-2
• Histologically confirmed primary oral squamous cell carcinoma (including tongue, gingival, buccal, oral base, hard palate, posterior molar area)
• Clinical stage III/IVA (cT1-2/N1-2/M0 or cT3-4a/N0-2 /M0, AJCC 8th)
• The combined positive score (CPS score) of PD-L1 expression \> 10
• Has signed informed consent
Locations
Other Locations
China
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Lai-ping Zhong, MD, PhD
zhonglp@hotmail.com
+862123271699
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 46
Treatments
Experimental: Neoadjuvant arm
The patients received three cycles of neoadjuvant therapy, with 14 days each. Dosage and administration: 200mg Carrelizumab intravenously on the first day of each cycle; Apatinib orally 250mg once a day from the first day of each cycle until the 9th day of the third cycle. Then the patients received the standard treatment of surgery and postoperative adjuvant therapy of radiotherapy or chemoradiotherapy.
No_intervention: Control arm
The patients received the standard treatment of surgery and postoperative adjuvant therapy of radiotherapy or chemoradiotherapy.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Jiao Tong University School of Medicine