Clinical trial · Interventional
Programmed Death-1 (PD-1) Antibody Combined With Chemoradiotherapy in High-risk Recurrent Nasopharyngeal Carcinoma
PD-1 Antibody Combined With Chemotherapy in High-risk Recurrent Nasopharyngeal Carcinoma: a Prospective, Open, Single-arm Phase II Clinical Trial
NCT03930498CI-TRIAL-00111039active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.
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 |
|---|---|---|---|
| Recurrent Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| IMRT | Radiation | — | UNRESOLVED |
| PD-1 blocking antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 antibody plus chemoradiotherapy
- interventionNames
- Drug: PD-1 blocking antibody
- Drug: Chemotherapy
- Radiation: IMRT
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 2 years
- description
- From date of recruitment to death
Secondary outcomes (5)
- measure
- Objective response rate
- timeFrame
- After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days)
- description
- Patient's short-term effect
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment; * Not suitable for surgery; * Newly histologic diagnosis of NPC (WHO II/III); * Clinical stage rII-IVa (AJCC/UICC 8th); * ECOG 0-1 point; * PRANCIS score \> 252 points; * No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy; * No contraindications to immunotherapy or chemoradiotherapy; * 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 two months after treatment; * Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: * Have recurrence with local necrosis; * Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa; * Unexplained fever \> 38.5 ℃, except for tumor fever; * Treated with ≥ 5 days antibiotics one month before enrollment; * 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 previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway; * 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
No reference posted for this study.