Clinical trial · Interventional
SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma
Stereotactic Body Radiotherapy (SBRT) and Low-dose Radiotherapy (LDRT) Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Prospective, Single-arm, Phase II Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| IMRT | Radiation | — | UNRESOLVED |
| Low-dose Radiotherapy (LDRT) | Radiation | — | UNRESOLVED |
| SBRT | Radiation | — | UNRESOLVED |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT+LDRT+PD-1+Chemotherapy
- description
- Patients will receive SBRT and LDRT one day before the GP chemotherapy and PD-1 antibody (six cycles), then followed by PD-1 antibody until progressive disease, intolerable toxicity, withdrawal of consent or a maximum of 2 year treatment.
- interventionNames
- Radiation: SBRT
- Radiation: Low-dose Radiotherapy (LDRT)
- Drug: Toripalimab
- Drug: Gemcitabine
- Drug: Cisplatin
- Radiation: IMRT
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- up to 12 months
- description
- Defined as the time from randomization to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed as recurrence/metastatic NPC * Histopathological diagnosis of NPC(WHO II/III) * ECOG 0-1 point * No treatment to r/mNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy; * No contraindications to immunotherapy and chemoradiotherapy; * At least one lesion could receive SBRT safely; * Subject must have a measurable target lesion based on RECIST v1.1; * Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/ L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L; * Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN; * Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula); * Take effective contraceptions during and three months after treatment; * Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: * Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin; * Unexplained fever \> 38.5 #, except for tumor fever; * Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); * Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive; * Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; Have known allergy to large molecule protein products or any compound of study therapy; * Pregnant or breastfeeding; * Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma; * Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial; * Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
References
Publications (0)
Data not yet available