Neoplasms

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Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

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Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

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Apatinib

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

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.

The patients received the standard treatment of surgery and postoperative adjuvant therapy of radiotherapy or chemoradiotherapy.

The patients will receive three cycles of Camrelizumab, with 14 days each. 200mg of Carrelizumab will be used intravenously on the first day of each cycle.

Camrelizumab (anti-PD-1 inhibitor)

The patients will receive Apatinib orally 250mg once a day from the first day of each cycle until the 9th day of the third cycle.

Apatinib (anti-VEGFR inhibitor)

Lai-ping Zhong, MD, PhD

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.

In the previous "Icemelting" trial, neoadjuvant anti-PD-1 plus anti-VEGFR therapy was used in 20 patients with locally advanced and resectable oral squamous cell carcinoma (OSCC), and the neoadjuvant therapy was well-tolerated, with no grade 3-4 toxicity. The MPR rate was 40% (8/20), including 5% (1/20) pathological complete response; furthermore, in the patients with CPS\>10, the MPR rate was 100%. As we know, the MPR might transfer to survival benefit in the patients received neoadjuvant therapy. Therefore, in this randomized phase II trial, we aimed to evaluate the survival benefit of neoadjuvant anti-PD-1 plus anti-VEGFR therapy in the patients with locally advanced OSCC and CPS\>10 (Icemelting-2 trial). A total of 46 patients will be enrolled in this trial, and the primary endpoint is 2-year disease-free survival rate. The neoadjuvant therapy arm will receive three cycles of Carrelizumab plus Apatinib with 14 days each, followed by the standard treatment of surgery and postoperative adjuvant therapy. The control arm will received the standard treatment of surgery and postoperative adjuvant therapy.

Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients

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

The study protocol and the primary study report might be shared depending on the condition of trial completion.

Disease-free survival was calculated from the date of randomization to tumor recurrence or death from any cause.

Overall survival was calculated from the date of randomization to death from any cause.

The major pathological response (MPR): the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of residual viable tumor (RVT) cells was evaluated on resected tumor slides. MPR was defined as ≤ 10% RVT%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients	NCT05069857	Oral Squamous C... Neoadjvant Ther... Anti-PD-1 Anti-VEGFR	Camrelizumab (a... Apatinib (anti-...	18 Years - 75 Years	Shanghai Jiao Tong University School of Medicine
Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients	NCT05069857	Oral Squamous C... Neoadjvant Ther... Anti-PD-1 Anti-VEGFR	Camrelizumab (a... Apatinib (anti-...	18 Years - 75 Years	Shanghai Jiao Tong University School of Medicine

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