Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Envafolimab group 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. |
Drug: Envafolimab Plus Chemoradiotherapy
Envafolimab was administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.
|
Outcome Measures
Primary Outcome Measures
- 3-year progression free survival [3-year]
time from the randomization to the first disease progression or death
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B2022-203-01