Clinical trial · Interventional
Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.
Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II 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)
Patients diagnosed with locally advanced nasopharyngeal carcinoma will be recruited in this study. All the patients will get 3 cycles of GP+ Envafolimab for the induction chemotherapy. After that, the patients will receive concurrent chemoradiotherapy. Radiotherapy will be given by IMRT, under the dose of GTVnx 68-70Gy/30-33f, 5d/w,6-7w, during which, every patient would receive 2 cycles of DDP+Envafolimab as concurrent chemotherapy. Then patients would receive Envafolimab every 3 weeks for maintenance treatment for a year, until disease progression or intolerance of treatment. . We aim to evaluate the three years progression free survival of these patients by the combination of Envafolimab with curative chemoradiotherapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Envafolimab | — | UNRESOLVED | — |
| Induction Chemotherapy | — | UNRESOLVED | — |
| Locally Advanced Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
| PD-L1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Envafolimab Plus Chemoradiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Envafolimab group
- description
- Envafolimab is a PD-L1 antibody by hypodermic injection. Envafolimab will be administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.
- interventionNames
- Drug: Envafolimab Plus Chemoradiotherapy
Primary outcomes (1)
- measure
- 3-year progression free survival
- timeFrame
- 3-year
- description
- time from the randomization to the first disease progression or death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG 0-1 * histologically confirmed non-keratinizing carcinoma (WHO type II or III) of nasal pharynx * stage III-IVa （AJCC/UICC 8th ）, untreated NPC patients * NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L * ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN * creatinine\<1.5×ULN Exclusion Criteria: * recurrent or metastatic NPC patients * histologically confirmed keratinizing carcinoma (WHO type I) of nasal pharynx * already received radiation or chemotherapy * pregnant or lactating women, or women of childbearing age without birth control * HIV (+) * had other cancers before * used immune checkpoint inhibitor(CTLA-4、PD-1、PD-L1 etc.) before * complications requiring long-term treatment with immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive dose * with immune deficiency diseases, or a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and hypothyroidism; Patients with vitiligo or asthma in childhood who have completely relieved and do not need any intervention after adulthood can be included; Asthma requiring medical intervention with bronchodilators cannot be included) * use of massive dose of glucocorticoids within 4 weeks before enrollment * laboratory test values do not meet relevant standards within 7 days before enrollment * significantly lower functions of heart, liver, lung, kidney and bone marrow * serious or uncontrolled medical diseases or infections * participating other clinical trial in the same time * HBsAg (+) and HBV DNA \>1×10E3 copiers /mL * HCV (+) unless HCV RNA PCR(-) * with any other treatment contraindications
References
Publications (0)
Data not yet available