Toripalimab Plus Anlotinib Combined with GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for High-risk, Locally Advanced Nasopharyngeal Carcinoma:A Single-arm, Phase II Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

In order to explore the efficacy and safety of targeted therapy and immunotherapy combined with GP chemotherapy in the treatment of high risk advanced nasopharyngeal carcinoma, the investigators design a single-arm, Phase II clinical trial targeted high-risk patients with local stage nasopharyngeal carcinoma (stage IVa: TanyN3M0/T4N0-2M0,8th AJCC/UICC staging) for Toripalimab Plus Anlotinib Combined With GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Voluntarily participate in and sign informed consent in person.

• Age 18-65, male or non-pregnant female.

• Pathological diagnosis of nasopharyngeal non-keratonic carcinoma (differentiated or undifferentiated, i.e., WHO type II or III).

• First treatment patients who did not receive antitumor therapy had no history of other malignant tumors;

• Stage IVa: TanyN3M0/T4N0-2M0 (8th AJCC/UICC stage)

• ECOG score 0-1, no serious dysfunction of heart, lung, liver, kidney and other vital organs.

• Hemoglobin (HGB) ≥90 g/L, white blood cells (WBC) ≥4.0×109 /L, platelets (PLT) ≥100×109 /L.

• Liver function: ALT and AST\< 2.5 times the upper limit of normal (ULN), total bilirubin \<2.0×ULN.

• Renal function: serum creatinine \<1.5×ULN.

Locations
Other Locations
China
Sun yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Yi-Jun Hua, Phd.
huayj@sysucc.org.cn
18820019088
Time Frame
Start Date: 2025-01-03
Estimated Completion Date: 2027-06
Participants
Target number of participants: 47
Treatments
Experimental: Experimental group
Toripalimab Plus Anlotinib Combined With GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov