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

NCT ID: NCT05397769

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2026-12-31

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.

Conditions

Locally Advanced Nasopharyngeal Carcinoma; Envafolimab; Induction Chemotherapy; PD-L1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Envafolimab Plus Chemoradiotherapy

Intervention Type: DRUG

Envafolimab was administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Fei Han

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fei Han

Role: CONTACT

hanfei@sysucc.org.cn

13822113698 ext. 86

Xiaohui Wang

Role: CONTACT

wangxh@sysucc.org.cn

18826260661 ext. 86

Facility Contacts

Fei Han

Role: primary

hanfei@sysucc.org.cn

13822113698 ext. 86

Other Identifiers

B2022-203-01

Identifier Type: -

Identifier Source: org_study_id