LDRT Combined With Toripalimab and Chemotherapy for Recurrent/Metastatic NPC

NCT07325539 | Recruiting Phase 2 DMC

• 1 other identifier: 2025-FXY-451-FLK
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of LDRT combined with toripalimab and GP chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma through a prospective, open-label, single-arm Phase II clinical trial.

Conditions

Nasopharangeal Cancer; Nasopharyngeal Cancinoma (NPC)

Keywords

PD-1 antibody; Low dose radiotherapy; Recurrent/Metastatic Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) assessed by RECIST 1.1

  PFS was defined as the time from enrollment to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first.

  up to approximately 2 years

Secondary Outcomes (4)

• Objective Response Rate（ORR）

  up to approximately 2 years

• Progression-free survival (PFS) assessed by iRECIST

  up to approximately 2 years

• Overall survival (OS)

  up to approximately 4 years

• Adverse events

  up to approximately 2 years

Study Arms (1)

LDRT + Toripalimab + GP chemotherapy

EXPERIMENTAL

Patients will receive LDRT plus toripalimab and GP chemotherapy for 4-6 cycles, then followed by toripalimab until disease progression or unacceptable toxicity.

Drug: Gemcitabine(GEM); Drug: Cisplatin; Drug: Toripalimab; Radiation: LDRT

Interventions

Gemcitabine(GEM) DRUG

Gemcitabine 1000mg/m2, d1 \& 8 of every cycle, every 3 weeks for 4-6 cycles

LDRT + Toripalimab + GP chemotherapy

Toripalimab DRUG

Toripalimab 240 mg, d1of every cycle, every 3 weeks for 4-6 cycles. Toripalimab maintenance, 240 mg, d1of every cycle, every 3 weeks until disease progression or unacceptable toxicity.

LDRT + Toripalimab + GP chemotherapy

Cisplatin DRUG

Cisplatin 80mg/m2, d1 of every cycle, every 3 weeks for 4-6 cycles

LDRT + Toripalimab + GP chemotherapy

LDRT RADIATION

Irradiation of the primary lesion and regional metastatic lymph nodes, 0.5 Gy per fraction for 4 fractions, d0-3, every 3 weeks for 4-6 cycles

LDRT + Toripalimab + GP chemotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years old.
• Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II or III).
• ECOG Performance Status score of 0-1.
• At least one measurable lesion as per RECIST v1.1 criteria.
• Patients with newly diagnosed metastatic NPC, or patients with locoregionally advanced NPC who developed metastasis ≥6 months or recurrence ≥12 months after completing radical radiotherapy/chemotherapy for the primary lesion.
• No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent/metastatic lesions.
• Adequate organ function, meeting the following criteria within 7 days prior to treatment:
• Hematological criteria (without transfusion or hematopoietic growth factor support within 14 days):
• Hemoglobin (Hb) ≥90 g/L.
• White Blood Cell (WBC) count ≥4.0 × 10⁹/L.
• Platelet count (PLT) ≥100 × 10⁹/L.
• Biochemical criteria:
• Total Bilirubin (TBIL) ≤1.5 × Upper Limit of Normal (ULN).
• Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5 × ULN.
• Serum Creatinine (Cr) ≤1.5 × ULN AND Creatinine Clearance (CCr) ≥60 mL/min.

You may not qualify if:

• Disease progression within 6 months after completing standard treatment for locoregionally advanced nasopharyngeal carcinoma.
• Absence of identifiable tumor lesions in both the primary site and locoregional lymph nodes, precluding the development of an LDRT plan.
• Inability to undergo MRI due to reasons such as implanted metal devices or claustrophobia.
• Requirement for systemic use of corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose or during the study. Inhaled or topical steroids and adrenal replacement steroid doses \>10 mg/day prednisone equivalent are permitted in the absence of active autoimmune disease. Physiological replacement doses of corticosteroids (≤10 mg/day prednisone equivalent) are allowed.
• Recurrent target lesions suitable for curative surgery or a second course of radiotherapy.
• History of any active autoimmune or autoimmune disease, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. Exceptions include type I diabetes, hypothyroidism requiring hormone replacement therapy, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
• Active or uncontrolled severe infection (≥CTCAE Grade 3) within 4 weeks prior to enrollment.
• History of active tuberculosis within the past year, regardless of treatment. Patients with a history of active pulmonary tuberculosis over 1 year ago who have documented evidence of adequate past anti-tuberculosis treatment may be considered; otherwise, they are excluded.
• History of hypertension that cannot be adequately controlled with a single antihypertensive medication (systolic BP ≥150 mmHg or diastolic BP ≥90 mmHg).
• Clinically significant bleeding symptoms or definite bleeding tendency, specifically excluding cases of local recurrence with high bleeding risk or cases within 1 year post-radiotherapy assessed to have a high risk of necrosis.
• Urinalysis showing urine protein ≥ ++ AND confirmed 24-hour urine protein ≥1.0 g.
• Myocardial ischemia (above Grade I), myocardial infarction, arrhythmia (including QTc ≥480 ms), or ≥ Grade 2 congestive heart failure (NYHA classification) within 6 months prior to enrollment.
• Diagnosis of other malignancies within 5 years prior to enrollment, except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
• Presence of leptomeningeal or central nervous system metastases.
• HIV positive, TP positive, liver cirrhosis, decompensated liver disease, active hepatitis (uncontrolled active hepatitis despite treatment: Hepatitis B - HBsAg positive and HBV DNA ≥1 × 10⁴ copies/mL; Hepatitis C - HCV RNA positive with abnormal liver function; co-infection with HBV and HCV) requiring antiviral therapy.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Related Publications (16)

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MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Gemcitabine; Cisplatin; toripalimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jun Ma, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Ma, M.D.

CONTACT

+862087343469; majun2@mail.sysu.edu.cn

Zhe Li, Ph.D.

CONTACT

+862087342370; lizhe2@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)