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A prospective, single-arm, exploratory study of neoadjuvant Camrelizumab combined with Nimotuzumab for stage II-IVa resectable oral squamous cell carcinoma

A prospective, single-arm, exploratory study of neoadjuvant Camrelizumab combined with Nimotuzumab for stage II-IVa resectable oral squamous cell carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047855
Enrollment
Unknown
Registered
2021-06-27
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral squamous cell carcinoma

Interventions

Experimental group:Carrelizumab + Nimotuzumab

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Pathologically diagnosed patients with oral squamous cell carcinoma who meet the following conditions: (1) Newly diagnosed patients with stage II-IVa oral squamous cell carcinoma without distant metastasis; (2) Surgical resection is possible after evaluation by head and neck surgery; (3) Willing to accept surgical treatment; 3. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1; 4. Having adequate organ and bone marrow function, as defined below: (1) Blood routine: neutrophil count (NEUT#) >= 1.5x10^9/L; platelet (PLT) >= 100x10^9/L; hemoglobin >= 9 g/dL; (2) Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) = 2.8 g/dL; (4) Renal function: creatinine clearance (CCR) > 60 ml/min; (5) Coagulation function: international normalized ratio (INR) <= 1.5; partial thromboplastin time (APTT) <= 1.5 ULN; 5. The subjects voluntarily joined the study, signed the informed consent, and were able to comply with the visits and related procedures stipulated in the protocol.

Exclusion criteria

Exclusion criteria: 1. The patient has any active autoimmune disease or has a history of autoimmune disease; 2. Patients who cannot guarantee the completion of the necessary treatment plan and follow-up observation; 3. Other researchers think that it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Pathologic complete rate;

Secondary

MeasureTime frame
major pathological response rate;Objective response rate;Disease-free survival;Overall survival;Safty;

Countries

China

Contacts

Public ContactPeng Xingchen

West China Hospital, Sichuan University

pxx2014@163.com+86 18980606753

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026