Tislelizumab Plus Chemotherapy With Response-Adapted Radiotherapy for de Novo Metastatic Nasopharyngeal Carcinoma: A Prospective, Phase II Trial

Chongqing University Cancer Hospital

Status: Active, not recruiting

Conditions: Nasopharyngeal Cancinoma (NPC)

Treatments: Radiation: response-adapted radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07248696

Daybreak-01

Details and patient eligibility

About

This study is aimed to evaluate the efficacy and safety of tislelizumab combined with chemotherapy and response-adapted radiotherapy in patients with de novo metastatic nasopharyngeal carcinoma

Full description

This is a prospective phase II study that enrolled patients with previously untreated de novo metastatic nasopharyngeal carcinoma who achieved either a complete response (CR) or partial response (PR) after 4-6 cycles of treatment with gemcitabine plus cisplatin (GP regimen) chemotherapy combined with tislelizumab. Based on tumor response stratification, these patients received locoregional radiotherapy and radiotherapy for metastatic lesions, followed by sequential tislelizumab maintenance therapy.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-70 years.
2. Newly diagnosed nasopharyngeal carcinoma with pathological confirmation of non-keratinizing carcinoma (WHO type II or III).
3. Stage IV (T1-4N0-3M1a and M1b) according to the AJCC/UICC 9th edition clinical staging system for NPC.
4. Achieved complete response (CR) or partial response (PR) by imaging evaluation after 4-6 cycles of GP chemotherapy combined with tislelizumab.
5. ECOG performance status: 0-1.
6. Adequate organ function.

Exclusion criteria

1. Recurrent or metastatic nasopharyngeal carcinoma after radical treatment.
2. Other malignancies diagnosed or treated within the past 5 years (except basal cell carcinoma, cervical carcinoma in situ, and superficial bladder tumors).
3. Previous treatment with immune checkpoint inhibitors.
4. Pregnancy or lactation (consider pregnancy testing for women of childbearing age and emphasize effective contraception during treatment).
5. Active or history of autoimmune diseases.
6. Concurrent medical condition requiring the use of immunosuppressive medications.
7. Active hepatitis B or C infection.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

response-adapted radiotherapy

Experimental group

Description:

This is a prospective phase II study that enrolled patients with previously untreated de novo metastatic nasopharyngeal carcinoma who achieved either a complete response (CR) or partial response (PR) after 4-6 cycles of treatment with gemcitabine plus cisplatin (GP regimen) chemotherapy combined with tislelizumab. Based on tumor response stratification, these patients received locoregional radiotherapy and radiotherapy for metastatic lesions, followed by sequential tislelizumab maintenance therapy.

Treatment:

Radiation: response-adapted radiotherapy