Phase II Trial of Neoadjuvant and Adjuvant Anti-PD-1 Antibody Toripalimab Combined With CCRT in NPC Patients

Phase

Condition

Nasopharyngeal Cancer

Carcinoma

Treatment

N/A

Clinical Study ID

NCT03925090

B2019-014-01

Ages 18-65
All Genders

Study Summary

This is a randomized Phase II trial to study the effectiveness and toxicity of neoadjuvant and adjuvant PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy versus cisplatin concurrent chemoradiotherapy plus placebo in treating patients with high risk locoregionally advanced nasopharyngeal carcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing nasopharyngealcarcinoma, including WHO II or III Original clinical staged as III-IVa （according tothe 8th AJCC edition）
No evidence of distant metastasis (M0)
Plasm EB Virus DNA≥1500copies/ml
Male and no pregnant female
Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
With normal renal function test ( creatinine clearance ≥60 ml/min)

Exclusion

Exclusion Criteria:

Patients have evidence of relapse or distant metastasis
Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
Receiving radiotherapy or chemotherapy previously
The presence of uncontrolled life-threatening illness
Women of child-bearing potential who are pregnant or breastfeeding because of thepotentially dangerous effects of the preparative chemotherapy on the fetus or infant.
Suffered from other malignant tumors (except the cure of basal cell carcinoma oruterine cervical carcinoma in situ) previously.
Patients who have been treated with inhibitors of immune regulation (CTLA-4, PD-1,PD-L1, etc.).
Patients with immunodeficiency disease and history of organ transplantation.
Patients who have used large doses of glucocorticoids, anti-cancer monoclonalantibodies, and other immunosuppressive agents within 4 weeks.
HIV positive.
Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
Severe, uncontrolled medical conditions and infections.
At the same time using other test drugs or in other clinical trials.
Refusal or inability to sign informed consent to participate in the trial.
Other treatment contraindications.
Emotional disturbance or mental illness, no civil capacity or limited capacity forcivil conduct.
Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
Patients with positive HCV antibody test results can only be included in the studywhen the polymerase chain reaction of HCV RNA is negative.

Study Design

December 08, 2019

October 31, 2023

Study Description

Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. For locoregionally advanced NPC, especially for the high risk NPC (plasma EBV DNA ≥ 1500 copies/ml), the incidence of treatment failure is still high. Although concurrent chemoradiotherapy (CCRT) can improve the treatment outcomes of these patients, approximately 25% of locoregionally advanced NPCs still develop relapse and metastasis.

Hence, there is an urgent need for novel therapies to improve survival and reduce treatment-related toxicity in NPC patients. Accumulating evidence shows that PD-1 antibody is effective for treating recurrent/metastastic NPC patients. This is a Phase II randomized trial to study the effectiveness and toxicity of neoadjuvant and adjuvant PD-1 antibody Toripalimab combined with CCRT versus CCRT plus placebo in treating patients with high risk NPC (Stage III-IVa, AJCC 8th and EBV DNA ≥ 1500 copies/ml).

Connect with a study center

Sun Yat-sen Universitty Cancer Center
Guangzhou, Guangdong 510060
China
Active - Recruiting

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