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

NCT05069857 | Recruiting Phase 2

• 1 other identifier: Icemelting-2
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Squamous Cell Carcinoma; Neoadjvant Therapy; Anti-PD-1; Anti-VEGFR

Outcome Measures

Primary Outcomes (1)

• 2-year disease-free survival rate

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

  24 months

Secondary Outcomes (2)

• 2-year overall survival rate

  24 months

• Major pathological response

  3 months

Study Arms (2)

Neoadjuvant arm

EXPERIMENTAL

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.

Drug: Camrelizumab (anti-PD-1 inhibitor); Drug: Apatinib (anti-VEGFR inhibitor)

Control arm

NO INTERVENTION

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

Interventions

Camrelizumab (anti-PD-1 inhibitor) DRUG

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.

Neoadjuvant arm

Apatinib (anti-VEGFR inhibitor) DRUG

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.

Neoadjuvant arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Toxicity of ≥ grade 2 (CTCAE 5.0) that has not subsided due to previous anticancer therapy
• Obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, ≥ grade 2 heart disease diagnosed according to the NYHA classification criteria within 3 months prior to enrollment)
• Active severe clinical infection (\> NCI-CTCAE Version 5.0 level 2 infection)
• Uncontrollable hypertension (systolic blood pressure \> after antihypertensive medication; 150mmHg and/or diastolic blood pressure \> 90mmHg) or clinically significant (such as activity) cardiovascular disease, such as cerebrovascular accident (≤ 6 months before screening), myocardial infarction (≤ 6 months before screening), unstable angina, congestive heart failure rated class II or above by NYHA, or severe arrhythmias that cannot be controlled or have a potential impact on trial treatment
• Blood routine examination: WBC \< 3,000/mm3, hemoglobin \< 8g/L, platelet \< 80,000/mm3
• Liver function: ALAT/ASAT \> 2.5 times the normal upper limit, bilirubin \> 1.5 times the normal upper limit
• Renal function: serum creatinine \> 1.5 times the normal upper limit
• Has a history of maxillofacial and neck radiotherapy
• Pregnant or lactating women
• Participation in other clinical studies within 30 days prior to enrollment
• Other conditions that the investigator considers inappropriate for participation

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 20011, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Lai-ping Zhong, MD, PhD

  Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lai-ping Zhong, MD, PhD

CONTACT

+862123271699; zhonglp@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 6, 2021
• Study Start: September 1, 2021
• Primary Completion: August 30, 2024
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)