Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.

Induction Chemotherapy Clinical Trial

Official title:

Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397769
• Other study ID #: B2022-203-01
• Status: Recruiting
• Phase: Phase 2
• Start date: June 8, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2022
• Source: Sun Yat-sen University
• Contact: Fei Han
• Phone: 13822113698
• Email: hanfei[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 31, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Induction Chemotherapy
• Locally Advanced Nasopharyngeal Carcinoma
• Nasopharyngeal Carcinoma
• PD-L1

Intervention

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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year progression free survival	time from the randomization to the first disease progression or death	3-year