Clinical trial NCT05397769: Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.
Official title: Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Nasopharyngeal Carcinoma
Envafolimab
Induction Chemotherapy
PD-L1
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 3-year progression free survival
timeFrame: 3-year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: