GAPP Induction and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance for Nasopharyngeal Carcinoma.

NCT ID: NCT06851247

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-03
• Study Completion Date: 2027-06-30

Brief 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.

Detailed Description

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. The investigators focus on the 2-year PFS as the primary outcome.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Toripalimab Plus Anlotinib Combined With GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

Fixed dose: 240mg/ time, add 100ml normal saline, intravenous infusion for 30 minutes (not less than 20 minutes, not more than 60 minutes).

The first course of induction chemotherapy (D1) is used on the first day of each cycle, and every 21 days is a course of treatment up to 18 courses or one year.

After intravenous infusion of triplelizumab, GP regimen induction chemotherapy was administered at an interval of 30-60 minutes.

Anlotinib

Intervention Type: DRUG

Oral administration before breakfast, 10mg/ time/day, once a day (d1-14), repeated every 3 weeks, using three courses, one week before radiotherapy discontinuation.

Use on the day the first course of induction chemotherapy begins (D1).

Gemcitabine

Intervention Type: DRUG

1000mg/m2, D1, D8, add 0.9% normal saline 500ml, intravenous infusion. Every 21 days is a treatment cycle. If the recovery of toxicity in the subject is not sufficient for the next course of chemotherapy, the start of the next course of chemotherapy may be appropriately delayed, but the delay cannot exceed 21 days.

The treatment was continued for 3 courses.

Cisplatin

Intervention Type: DRUG

Induction Chemotherapy: 80mg/m2, D1, add 1000ml 0.9% normal saline, intravenous infusion for 3 hours.

Concurrent Chemoradiotherapy100mg/m2, add 5% glucose 500ml, intravenous drip. Use on the first day of each cycle, every 21 days for a treatment cycle

radiation

Intervention Type: RADIATION

IMRT, 33Fx

Interventions

Toripalimab

Fixed dose: 240mg/ time, add 100ml normal saline, intravenous infusion for 30 minutes (not less than 20 minutes, not more than 60 minutes).

The first course of induction chemotherapy (D1) is used on the first day of each cycle, and every 21 days is a course of treatment up to 18 courses or one year.

After intravenous infusion of triplelizumab, GP regimen induction chemotherapy was administered at an interval of 30-60 minutes.

Intervention Type: DRUG

Anlotinib

Oral administration before breakfast, 10mg/ time/day, once a day (d1-14), repeated every 3 weeks, using three courses, one week before radiotherapy discontinuation.

Use on the day the first course of induction chemotherapy begins (D1).

Intervention Type: DRUG

Gemcitabine

1000mg/m2, D1, D8, add 0.9% normal saline 500ml, intravenous infusion. Every 21 days is a treatment cycle. If the recovery of toxicity in the subject is not sufficient for the next course of chemotherapy, the start of the next course of chemotherapy may be appropriately delayed, but the delay cannot exceed 21 days.

The treatment was continued for 3 courses.

Intervention Type: DRUG

Cisplatin

Induction Chemotherapy: 80mg/m2, D1, add 1000ml 0.9% normal saline, intravenous infusion for 3 hours.

Concurrent Chemoradiotherapy100mg/m2, add 5% glucose 500ml, intravenous drip. Use on the first day of each cycle, every 21 days for a treatment cycle

Intervention Type: DRUG

radiation

IMRT, 33Fx

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients with recurrent and distant metastasis of nasopharyngeal carcinoma.
• The pathology was keratinized squamous cell carcinoma (WHO type I).
• Received systemic or local glucocorticoid therapy within 4 weeks prior to enrollment.
• Participants who had participated in other drug clinical trials within 3 months before treatment.
• Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Patients with idiopathic pulmonary fibrosis, drug-induced pneumonia, institutional pneumonia (i.e., bronchiolitis obliterans), radiation pneumonia with clinical symptoms or requiring steroid treatment, active pneumonia, or other moderate to severe lung diseases that seriously affect lung function
• Have a comorbiditis that requires long-term treatment with immunosuppressive drugs or systemic or local use of immunosuppressive doses of corticosteroids.
• Prior use of anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibody that acts on the T-cell co-stimulation or checkpoint pathway), and efficacy was assessed as progressive at enrollment.
• The subject has any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; Patients with vitiligo or who had complete remission of asthma in childhood and did not require any intervention as adults were included; Patients with asthma requiring medical intervention with bronchodilators were not included).
• Positive HBV DNA copy number was detected in HIV-positive patients and HBsAg positive patients (quantitative detection ≥ 1000cps/ml); Chronic hepatitis C blood screening positive (HCV antibody positive) with HCV RNA positive detection.
• Received any anti-infection vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment.
• Pregnancy test positive women of childbearing age and breastfeeding women.
• Patients who are unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

YiJun Hua

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi-Jun Hua, Phd.

Role: CONTACT

huayj@sysucc.org.cn

18820019088

Facility Contacts

Hua-Yi Jun, Phd

Role: primary

huayj@sysucc.org.cn

18820019088

Other Identifiers

2024-FXY-171-NPC

Identifier Type: -

Identifier Source: org_study_id