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

Launched by SUN YAT-SEN UNIVERSITY · May 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced nasopharyngeal carcinoma (NPC), a type of cancer found in the area behind the nose. In this trial, all participants will receive a combination of a medication called Envafolimab and a standard chemotherapy regimen. First, they will undergo three cycles of induction chemotherapy, followed by a period of combined chemotherapy and radiation therapy. After this, participants will continue to receive Envafolimab every three weeks for a year to help prevent the cancer from coming back. The main goal of the trial is to see how well this combination treatment helps patients remain cancer-free for three years.

To be eligible for this study, participants should be adults with untreated stage III-IVa NPC, and their overall health should be fairly good (with a performance status score of 0 or 1). They should not have any other active cancers, previous treatments for NPC, or certain health conditions that might complicate participation. Throughout the study, patients will have regular check-ups to monitor their health and treatment response. This trial is currently recruiting participants, and it aims to provide valuable insights into the effectiveness of combining Envafolimab with traditional treatment methods for NPC.

Gender

ALL

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