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Concurrent Chemoradiotherapy With Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Trial

Primary Purpose

Nasopharyngeal Carcinoma, Toripalimab, Recurrent Nasopharyngeal Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Toripalimab

About this trial

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

Eligibility Criteria

18 Years - 70 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 recurrence 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> 70, or < 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 Type

Experimental

Arm Label

Toripalimab+CCRT

Arm Description

Cisplatin 100mg/m2(every three weeks),D1,D22,D43 of intensity modulated radiotherapy. Toripalimab 240mg every 3 weeks with a total of 3 cycles as concurrent anti-PD-1 immunotherapy; Toripalimab240mg every 3 weeks with a total of 9 cycles as adjuvant anti-PD-1 immunotherapy 3 weeks after CCRT

Outcomes

Primary Outcome Measures

Overall survival

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) from the National Cancer Institute (NCI).

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

NCT04992988

First Posted

July 18, 2021

Last Updated

August 16, 2021

Sponsor

Cancer Hospital of Guangxi Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04992988

Brief Title

Concurrent Chemoradiotherapy With Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Trial

Official Title

Concurrent Chemoradiotherapy With Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 28, 2020 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

June 2022 (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 prospective, single-arm, phase II trial to study the efficacy of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy 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

Nasopharyngeal Carcinoma, Toripalimab, Recurrent Nasopharyngeal Squamous Cell Carcinoma

Keywords

Nasopharyngeal Carcinoma, Toripalimab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Toripalimab+CCRT

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Toripalimab

Intervention Description

Toripalimab 240mg every 3 weeks with a total of 3 cycles as concurrent anti-PD-1 immunotherapy; Toripalimab240mg every 3 weeks with a total of 9 cycles as adjuvant anti-PD-1 immunotherapy 2 weeks after CCRT

Primary Outcome Measure Information:

Title

Overall survival

Description

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.

Time Frame

2 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

2 years

Title

Objective Response Rate （ORR）

Description

Time Frame

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

Title

Incidence rate of adverse events (AEs)

Description

Time Frame

2 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

70 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 recurrence 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> 70, or < 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.

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

Song Qu, Dr

Phone

+8613607887386

daisyqs2002@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Concurrent Chemoradiotherapy With Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Trial

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