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

NCT ID: NCT07248696

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-04
• Study Completion Date: 2029-06-30

Brief Summary

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

Detailed 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.

Conditions

Nasopharyngeal Cancinoma (NPC)

Study Design

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

Study Groups

response-adapted radiotherapy

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.

Group Type: EXPERIMENTAL

response-adapted radiotherapy

Intervention Type: RADIATION

Induction Treatment Regimen:

• Tislelizumab+Gemcitabine+Cisplatin for 4-6 cycles .

Response-Adapted Radiotherapy:

• Patients achieving CR after induction therapy require no radiotherapy.
• Patients achieving PR after induction therapy: Radiotherapy (55 Gy/20 fractions, 5 fractions per week, over 4 weeks) to the residual primary nasopharyngeal lesion and metastatic cervical lymph nodes. Radiotherapy for metastatic lesions concurrently or sequentially with locoregional radiotherapy.

Immunotherapy Regimen:

maintenance therapy with tislelizumab monotherapycontinues until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first. The total treatment duration shall not exceed 2 years

Interventions

response-adapted radiotherapy

Induction Treatment Regimen:

• Tislelizumab+Gemcitabine+Cisplatin for 4-6 cycles .

Response-Adapted Radiotherapy:

• Patients achieving CR after induction therapy require no radiotherapy.
• Patients achieving PR after induction therapy: Radiotherapy (55 Gy/20 fractions, 5 fractions per week, over 4 weeks) to the residual primary nasopharyngeal lesion and metastatic cervical lymph nodes. Radiotherapy for metastatic lesions concurrently or sequentially with locoregional radiotherapy.

Immunotherapy Regimen:

maintenance therapy with tislelizumab monotherapycontinues until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurs first. The total treatment duration shall not exceed 2 years

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chongqing University Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xin Zhang

Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Countries

China

References

Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. 2. Ng SH, Chan SC, Yen TC, et al. Pretreatment evaluation of distant-site status in patients with nasopharyngeal carcinoma: accuracy of whole-body MRI at 3-Tesla and FDG-PET-CT. Eur Radiol. 2009;19(12):2965-2976. 3. Zou X, You R, Liu H, et al. Establishment and validation of M1 stage subdivisions for de novo metastatic nasopharyngeal carcinoma to better predict prognosis and guide treatment. Eur J Cancer. 2017;77:117-126. 4. Zhang L, Huang Y, Hong S, et al. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016;388(10054):1883-1892. 5. Yang Y, Pan J, Wang H, et al. Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309). Cancer Cell. 2023;41(6):1061-1072 e1064. 6. Mai HQ, Chen QY, Chen D, et al. Toripalimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: The JUPITER-02 Randomized Clinical Trial. JAMA. 2023;330(20):1961-1970. 7. Yang Y, Qu S, Li J, et al. Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2021;22(8):1162-1174. 8. You R, Liu YP, Huang PY, et al. Efficacy and Safety of Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone in De Novo Metastatic Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020;6(9):1345-1352. 9. Chen SY, Duan XT, Li HF, et al. Efficacy of sequential chemoradiotherapy combined with toripalimab in de novo metastatic nasopharyngeal carcinoma: A phase II trial. Cell Rep Med.

Reference Type: RESULT

Other Identifiers

Daybreak-01

Identifier Type: -

Identifier Source: org_study_id