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Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma

Primary Purpose

Recurrent Nasopharyngeal Carcinoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Toripalimab

About this trial

This is an interventional treatment trial for Recurrent Nasopharyngeal Carcinoma focused on measuring Recurrent Nasopharyngeal Carcinoma, Toripalimab, Concurrent chemoradiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor
staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition）
Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)
With normal renal function test ( creatinine clearance ≥60 ml/min)
sign an "informed consent form
Male and no pregnant female

Exclusion Criteria:

Age older than 65, or younger than 18 years old
Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml.
Patients with positive HCV antibody.
Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit.
History of interstitial lung disease
Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent.
Receive or will receive live vaccine within 30 days prior to signing the informed consent.
Women of child-bearing potential who are pregnant or breastfeeding.
Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.
Hypersensitivity to macromolecular protein, or to any component of triplezumab.
HIV positive.
Severe, uncontrolled medical conditions and infections.
Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.

Sites / Locations

Guangxi Medical University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Toripalimab+CCRT

CCRT alone

Arm Description

Toripalimab 240mg, and Cisplatin 100mg/m2 (every three weeks),D1,D22,D43 of intensity modulated radiotherapy (IMRT), followed by Toripalimab 240mg every 3 weeks with a total of 9 cycles as adjuvant anti-PD-1 immunotherapy. IMRT: total dose 60-66Gy, 1.8-2.0Gy/f

Cisplatin 100mg/m2(every three weeks),D1,D22,D43 of intensity modulated radiotherapy (IMRT). IMRT: total dose 60-66Gy, 1.8-2.0Gy/f

Outcomes

Primary Outcome Measures

Overall survival (OS)

Defined from date of randomization to date of first documentation of death from Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.

Secondary Outcome Measures

Progress-free survival (PFS)

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

Objective Response Rate (ORR)

An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) .

Incidence rate of adverse events (AEs)

Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0

Change of QoL (quality of life)

QoL scores were assessed by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) before radiotherapy, at the end of radiotherapy, at 12 months after radiotherapy.

Full Information

NCT ID

NCT04376866

First Posted

April 30, 2020

Last Updated

July 18, 2021

Sponsor

Cancer Hospital of Guangxi Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04376866

Brief Title

Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma

Official Title

Toripalimab in Combination With Concurrent Chemoradiotherapy for Local-regional Recurrent Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Recruiting

Study Start Date

June 28, 2020 (Actual)

Primary Completion Date

April 2023 (Anticipated)

Study Completion Date

April 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cancer Hospital of Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy versus cisplatin concurrent chemoradiotherapy alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.

Detailed Description

Nasopharyngeal carcinoma (NPC) is endemic in southern China, southeast Asia, and northern Africa. According to a survey from the International Agency for Research on Cancer, there were an estimated 129,079 new cases and 72,987 related deaths in 2018. Radiotherapy is the primary treatment option. Due to advances in disease management, diagnostic imaging, radiotherapy technology, and the broader application of systemic therapy, the prognosis of NPC has improved signifificantly.Nevertheless, localregional recurrence will occur in about 10% patients. Because of radiation resistance, the prognosis of re-irradiation is poor for recurrent nasopharyngeal carcinoma. Hence, there is an urgent need for novel therapies to improve survival and reduce treatment-related toxicity in recurrent NPC patients. Emerging evidence shows that PD-1 antibody is effective for treating recurrent/metastastic NPC patients. This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of neoadjuvant and adjuvant PD-1 antibody Toripalimab combined with concurrent chemoradiotherapy (CCRT) versus CCRT alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Nasopharyngeal Carcinoma

Keywords

Recurrent Nasopharyngeal Carcinoma, Toripalimab, Concurrent chemoradiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Toripalimab+CCRT

Arm Type

Experimental

Arm Description

Arm Title

CCRT alone

Arm Type

No Intervention

Arm Description

Cisplatin 100mg/m2(every three weeks),D1,D22,D43 of intensity modulated radiotherapy (IMRT). IMRT: total dose 60-66Gy, 1.8-2.0Gy/f

Intervention Type

Drug

Intervention Name(s)

Toripalimab

Other Intervention Name(s)

JS001

Intervention Description

anti-PD-1 antibody

Primary Outcome Measure Information:

Title

Overall survival (OS)

Description

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Progress-free survival (PFS)

Description

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

Time Frame

5 years

Title

Objective Response Rate (ORR)

Description

An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) .

Time Frame

3 months

Title

Incidence rate of adverse events (AEs)

Description

Time Frame

5 years

Title

Change of QoL (quality of life)

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition） Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1 Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN) With normal renal function test ( creatinine clearance ≥60 ml/min) sign an "informed consent form Male and no pregnant female Exclusion Criteria: Age older than 65, or younger than 18 years old Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml. Patients with positive HCV antibody. Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit. History of interstitial lung disease Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent. Receive or will receive live vaccine within 30 days prior to signing the informed consent. Women of child-bearing potential who are pregnant or breastfeeding. Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years. Hypersensitivity to macromolecular protein, or to any component of triplezumab. HIV positive. Severe, uncontrolled medical conditions and infections. Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Song Qu, PhD

Phone

86-13607887386

daisyqs2002@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhong-Guo Liang, Master

Phone

86-15878779785

liangzhongguo@gxmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Song Qu, PhD

Organizational Affiliation

Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangxi Medical University Cancer Hospital

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhong-Guo liang, PhD

Phone

+8615878779785

liangzhongguo@gxmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We will share the safety and efficacy data of the study

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Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma

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