Neoadjuvant Chemotherapytreatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

Phase 2

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma; Neoadjuvant Chemotherapy
• Interventions: Drug: Triprilimab combined with TP

• Registration Number: NCT05522985
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

The objective of research is to evaluate the efficacy and safety of treprizumab injection combined with AP regimen in the treatment of resectable locally advanced head and neck squamous cell carcinoma.122 patients were randomly divided into two groups: the test group (treprizumab injection combined with AP protocol) and the control group (TP protocol); The patients in both groups were treated with three cycles of induction therapy. After the induction therapy, the patients were evaluated and followed up with surgery.

Detailed Description

The case report form shall be filled by the investigator, and each selected case must complete the case report form. The completed case report form is used for data entry and management.

All original data were retained by the research department.Full analysis set: according to the principle of intention to analyze (ITT), all cases who received drug treatment and took drugs at least once were analyzed for efficacy. For the case data that cannot observe the whole treatment process, the last observation data shall be carried forward to the final results of the study (LOCF).

Per-protocol set: all cases that comply with the study protocol, have good compliance, have not taken prohibited drugs during the study period, and have completed the contents specified in the case report form. No imputation was performed for missing data. Fas and PPS were analyzed statistically for the efficacy of the drug.

Safety analysis set: all enrolled patients who have used the study drug at least once and have safety records after drug use belong to the safety analysis set. This data set was used for safety analysis.

All statistical analysis will be calculated by SPSS statistical analysis software. All statistical tests are conducted by two-sided test. If the p value is less than or equal to 0.05, the difference tested will be considered statistically significant. The confidence interval is 95%.

Baseline data were analyzed according to the full analysis set, and all efficacy indicators were analyzed according to the full analysis set and the compliance scheme set; The safety analysis set is adopted for the safety analysis.

The sample size calculated by pass 11.0 software: according to the existing literature, the PCR rate of neoadjuvant treatment for advanced head and neck squamous cell carcinoma in our bureau is about 16%, and it is expected that the combined treatment with treprizumab will be increased to 40%, so P1 is set to 40%. α= 0.05， β= 0.2, the sample size was calculated using Simon optimal two stage designs for phase II clinical trial model, and the planned number of enrolled cases was 122.

Study Timeline

• Study Start: 2021-11-07
• Status Verified: 2022-08
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-29
• Last Update Submitted: 2022-08-29
• Study First Posted: 2022-08-31
• Last Update Posted: 2022-08-31
• Primary Completion: 2022-11-07
• Study Completion: 2024-11-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TP（paclitaxel +cisplatin）	Triprilimab combined with TP	paclitaxel for injection (albumin binding type) 260 mg / m2, intravenous drip, D1, every 3 weeks as a cycle, a total of 3 cycles; cisplatin: 75mg / m2, intravenous drip, D1, once every 3 weeks, a total of 3 cycles;
Treprizumab combined with TP	Triprilimab combined with TP	treprizumab injection: 240mg once, intravenous infusion, D1, once every 3 weeks, a total of 3 cycles. paclitaxel for injection (albumin binding type) 260 mg / m2, intravenous drip, D1, every 3 weeks as a cycle, a total of 3 cycles; cisplatin: 75mg / m2, intravenous drip, D1, once every 3 weeks, a total of 3 cycles; Treprizumab was infused before and at least 60 minutes apart from chemotherapy; The intravenous infusion time of treprizumab shall be at least 60 minutes. Intravenous bolus or single rapid intravenous injection is not allowed.

Primary Outcome Measures

Name	Time	Method
PCR	9 weeks	Pathological complete response rate

Secondary Outcome Measures

Name	Time	Method
MPR	9 weeks	major pathological remission

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China