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

NCT05397769 | Recruiting Phase 2

• 1 other identifier: B2022-203-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 3-year progression free survival

  time from the randomization to the first disease progression or death

  3-year

Study Arms (1)

Envafolimab group

EXPERIMENTAL

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

Interventions

Envafolimab Plus Chemoradiotherapy DRUG

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

Envafolimab group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

envafolimab; Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Fei Han

CONTACT

13822113698; hanfei@sysucc.org.cn

Xiaohui Wang

CONTACT

18826260661; wangxh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: May 31, 2022
• Study Start: June 8, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)