Clinical trial · Interventional
PD-1 Blockade and Bevacizumab Replace Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma
PD-1 Inhibitor and Bevacizumab Replace Cisplatin in Induction, Concurrent, and/or Adjuvant Therapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma.
NCT05341193CI-TRIAL-00057978unknownPhase 1 / Phase 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)
At present, the treatment regimen of locally advanced nasopharyngeal carcinoma still needs to be further improved, and the focus of improvement lies in "replacing cisplatin with high-efficiency and low-toxicity treatment regimen". Considering the synergistic effect among radiotherapy, immunotherapy and anti-angiogenesis therapy, we chose PD-1 inhibitor combined with bevacizumab to replace cisplatin chemotherapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab+Toripalimab+gemcitabine, adjuvant with Bevacizumab and Toripalimab | Drug | — | UNRESOLVED |
| Bevacizumab+Toripalimab+gemcitabine, adjuvant with Toripalimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- low risk
- description
- Patients will receive induction therapy with toripalimab plus bevacizumab and gemcitabine every 3 weeks for 3 cycles before radiotherapy, then followed by IMRT and concurrent therapy with toripalimab plus bevacizumab for 2 cycles, then followed by adjuvant therapy with toripalimab every 3 weeks for a maximum of 1 year after radiotherapy.
- interventionNames
- Drug: Bevacizumab+Toripalimab+gemcitabine, adjuvant with Toripalimab
- type
- EXPERIMENTAL
- label
- high risk
- description
- Patients will receive induction therapy with toripalimab plus bevacizumab and gemcitabine every 3 weeks for 3 cycles before radiotherapy, then followed by IMRT and concurrent therapy with toripalimab plus bevacizumab for 2 cycles, then followed by adjuvant therapy with toripalimab and bevacizumab every 3 weeks for a maximum of 1 year after radiotherapy.
- interventionNames
- Drug: Bevacizumab+Toripalimab+gemcitabine, adjuvant with Bevacizumab and Toripalimab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntary participation with Written informed consent. 2. Age ≥ 18 years and ≤ 65 years. 3. Histologically confirmed with Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type). 4. Original clinical staged as III-IVa (according to the 8th AJCC edition). 5. Stage III patients should meet the criteria of EBV DNA≥4000 cps/ml. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 7. Patients must have adequate organ function: 1. White blood cell count (WBC)≥4.0×109 /L, Hemoglobin ≥ 90g/L, Platelet count ≥100×109/L. 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN),serum total bilirubin (TBIL) ≤2.0 times the upper limit of normal (ULN) . 3. Adequate renal function: creatinine clearance rate≥60 ml/min or Creatinine ≤1.5× upper limit of normal value. 4. INR, APTT≤1.5 x ULN. Exclusion Criteria: 1. Subjects with recurrent or metastatic nasopharyngeal carcinoma. 2. Histologically or cytologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx. 3. Prior therapy with systemic therapy for nasopharyngeal carcinoma. 4. Prior exposure to immune checkpoint inhibitors,including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies. 5. Prior exposure to antiangiogenic agents. 6. Tumor invasion to the intracranial with clinical symptoms accompanied by cerebral edema, requiring hormone therapy. 7. Any grade ≥2 bleeding event (according to CTCAE 5.0) occurred within 4 weeks prior to enrollment. 8. Subjects with an active, known or suspected autoimmune disease. 9. Subjects with clinically significant cardiovascular and cerebrovascular diseases. 10. Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs. 11. Subjects with previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency. 12. Subjects with arterial / venous thrombosis events occurred within 6 months of the first dose. 13. Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures. 14. Seropositivity for human immunodeficiency virus (HIV). 15. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
References
Publications (0)
Data not yet available
No reference posted for this study.