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

NCT03925090 | Unknown Phase 2

• 1 other identifier: B2019-014-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progress-free survival (PFS)

  Defined from date of randomization to date of first documentation of progression or death due to any cause, whichever occurred first.

  2 years

Secondary Outcomes (10)

• Overall Survival (OS)

  2 years

• Locoregional Relapse-Free Survival (LRRFS)

  2 years or until the date of the last follow-up visit.

• Distant Metastasis-Free Survival (DMFS)

  2 years

• Objective Response Rate （ORR）

  After the completion of the neoadjuvant PD-1 antibody and chemoradiotherapy treatment

• Incidence rate of adverse events (AEs)

  2 years

Study Arms (2)

Neoadjuvant and Adjuvant Toripalimab+CCRT

EXPERIMENTAL

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

Drug: Cisplatin+Toripalimab

Neoadjuvant and Adjuvant Placebo+CCRT

PLACEBO COMPARATOR

Drug: Cisplatin cisplatin 100mg/m2(every three weeks),D1,D22,D43 of intensity modulated radiotherapy Other Names: DDP Drug: placebo placebo 240mg every 2 weeks with a total of 2 cycles as neoadjuvant treatment; placebo 240mg every 3 weeks with a total of 8 cycles as adjuvant treatment 2 weeks after CCRT.

Drug: Cisplatin+placebo

Interventions

Cisplatin+Toripalimab DRUG

chemotherapy and monoclonal antibody

Also known as: DDP+ JS001

Neoadjuvant and Adjuvant Toripalimab+CCRT

Cisplatin+placebo DRUG

chemotherapy

Also known as: DDP

Neoadjuvant and Adjuvant Placebo+CCRT

Eligibility Criteria

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

You may qualify if:

• 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）
• 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)

You may not qualify if:

• 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 the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
• Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine 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 monoclonal antibodies, 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen Universitty Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (25)

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MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Overall Study Officials Mai, MD,PhD

  Sun Yat-Sen University Cancer Cente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Nasopharyngeal Carcinoma

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 23, 2019
• Study Start: December 8, 2019
• Primary Completion: December 6, 2021
• Study Completion: October 1, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CN (1)