Brief Title
Phase II Trial of Neoadjuvant and Adjuvant Anti-PD-1 Antibody Toripalimab Combined With CCRT in NPC Patients
Official Title
Randomized, Placebo-controlled, Double-blind Phase II Clinical Trial of Neoadjuvant and Adjuvant Anti-PD-1 Antibody Toripalimab Immunotherapy Combined With Concurrent Chemoradiotherapy for High-risk Nasopharyngeal Carcinoma
Brief 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.
Detailed 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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progress-free survival (PFS)
Secondary Outcome
Overall Survival (OS)
Condition
Nasopharyngeal Carcinoma
Intervention
Cisplatin+Toripalimab
Study Arms / Comparison Groups
Neoadjuvant and Adjuvant Toripalimab+CCRT
Description: Drug: Cisplatin cisplatin 100mg/m2(every three weeks),D1,D22,D43 of intensity modulated radiotherapy Other Names: DDP Drug: Toripalimab Toripalimab 240mg every 2 weeks with a total of 2 cycles as neoadjuvant anti-PD-1 immunotherapy; Toripalimab240mg every 3 weeks with a total of 8 cycles as adjuvant anti-PD-1 immunotherapy 2 weeks after CCRT Other Names:anti-PD-1 antibody, JS001
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
138
Start Date
December 8, 2019
Completion Date
October 2023
Primary Completion Date
October 2021
Eligibility Criteria
Inclusion Criteria:
1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal
carcinoma, including WHO II or III Original clinical staged as III-IVa （according to
the 8th AJCC edition）
2. No evidence of distant metastasis (M0)
3. Plasm EB Virus DNA≥1500copies/ml
4. Male and no pregnant female
5. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
6. WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
7. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
8. With normal renal function test ( creatinine clearance ≥60 ml/min)
Exclusion Criteria:
1. Patients have evidence of relapse or distant metastasis
2. Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
3. Receiving radiotherapy or chemotherapy previously
4. The presence of uncontrolled life-threatening illness
5. Women of child-bearing potential who are pregnant or breastfeeding because of the
potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
6. Suffered from other malignant tumors (except the cure of basal cell carcinoma or
uterine cervical carcinoma in situ) previously.
7. Patients who have been treated with inhibitors of immune regulation (CTLA-4, PD-1,
PD-L1, etc.).
8. Patients with immunodeficiency disease and history of organ transplantation.
9. Patients who have used large doses of glucocorticoids, anti-cancer monoclonal
antibodies, and other immunosuppressive agents within 4 weeks.
10. HIV positive.
11. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
12. Severe, uncontrolled medical conditions and infections.
13. At the same time using other test drugs or in other clinical trials.
14. Refusal or inability to sign informed consent to participate in the trial.
15. Other treatment contraindications.
16. Emotional disturbance or mental illness, no civil capacity or limited capacity for
civil conduct.
17. Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
18. Patients with positive HCV antibody test results can only be included in the study
when the polymerase chain reaction of HCV RNA is negative.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Overall Study Officials Mai, MD,PhD, 86-20-87343380, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03925090
Organization ID
B2019-014-01
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
Overall Study Officials Mai, MD,PhD, Principal Investigator, Sun Yat-Sen University Cancer Cente
Verification Date
April 2020