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Camrelizumab After Completion of Radiotherapy for Oligometastatic Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma, Oligometastasis, Radiotherapy

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Camrelizumab

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

Patients with histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
Patients with oligometastatic NPC (defined as ≤5 metastases, ≤2 organs), without local recurrence of nasopharynx.
Completion of radiotherapy 4-12 weeks prior to enrollment. At list one cycle of adjuvant platinum-based chemotherapy.
Satisfactory performance status: Karnofsky scale (KPS) > 70.
Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
Adequate renal function: creatinine clearance ≥50 ml/min.
Expected lifetime over 3 months
Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

Previous history of autoimmune disease or unstable autoimmune disease.
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections are not excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome are not excluded from the study.
Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Sites / Locations

Southern medical universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab

Arm Description

Camrelizumab 200mg every 21 days for up to 18 cycles, from 4 to 12 weeks after the completion of radiotherapy.

Outcomes

Primary Outcome Measures

Progression Free Survival

Time to progression or death from initiation of Camrelizumab

Drug toxicity and tolerability

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Life Quality

Evaluate patient quality of life by EORTC QLQ-C30 scale(Scores range from 0 to 100,a high functional scale score represents a high/healthy level of functioning, while a high symptom scale score indicates a high level of symptomatology or problems)

Overall Survival

Time to death from initiation of Camrelizumab

Full Information

NCT ID

NCT04221516

First Posted

January 6, 2020

Last Updated

June 14, 2023

Sponsor

Nanfang Hospital, Southern Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04221516

Brief Title

Camrelizumab After Completion of Radiotherapy for Oligometastatic Nasopharyngeal Carcinoma

Official Title

Camrelizumab After Completion of Radiotherapy for Oligometastatic Nasopharyngeal Carcinoma: A Phase 2 Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

February 1, 2024 (Anticipated)

Study Completion Date

February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The main purpose of this study is to see how well the experimental drug camrelizumab(SHR-1210) works in people with oligometastatic NPC who have already had locally radiotherapy for their disease. All patients will receive 200 mg of camrelizumab intravenously on Day 1 of each 21-day cycle. Patients will receive the study drug for up to 18 cycles.

Detailed Description

Each subject included in this project must sign an informed consent form. Within 4-6 weeks after completing radiotherapy and chemotherapy for oligometastatic lesions, subjects will receive camrelizumab 200 mg fixed-dose treatment every three-week (Q3W). If there is no confirmed disease progression, unacceptable adverse events or concurrent diseases (need further treatment ), the researcher decides to withdraw from the subject, the subject withdraws from treatment, the subject is pregnant, and other reasons that do not meet the requirements of the trial treatment or procedure, The treatment with camrelizumab will last at least 12 months. Patients with no signs of disease progression can be treated with another 6 to 12 months by the decision of researcher. After treatment, each subject will be followed up. Subjects should be monitored for adverse events for at least 30 days, and serious adverse events will be over 90 days. Subjects will be followed up 5 years from the last treatment or until one of the following events: ① disease progression; ② receive other treatments of cancer; ③ withdraw research consent; ④ loss of follow-up; ⑤ death.

6. Conditions and Keywords

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

Nasopharyngeal Carcinoma, Oligometastasis, Radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Camrelizumab

Arm Type

Experimental

Arm Description

Camrelizumab 200mg every 21 days for up to 18 cycles, from 4 to 12 weeks after the completion of radiotherapy.

Intervention Type

Drug

Intervention Name(s)

Camrelizumab

Intervention Description

Camrelizumab 200mg every 21 days (3 weeks) for up to 18 cycles, from 4 to 12 weeks after the completion of radiotherapy.

Primary Outcome Measure Information:

Title

Progression Free Survival

Description

Time to progression or death from initiation of Camrelizumab

Time Frame

3 years

Title

Drug toxicity and tolerability

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Life Quality

Description

Time Frame

3 years

Title

Overall Survival

Description

Time to death from initiation of Camrelizumab

Time Frame

3 years

Other Pre-specified Outcome Measures:

Title

Potential predictive biomarkers associated with therapeutic efficacy and prognosis

Description

PD-L1 expression;Tumor Mutational Burden(TMB);Tumor related gene changes; plasma EBV DNA copies ; cytokine; etc

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type). Patients with oligometastatic NPC (defined as ≤5 metastases, ≤2 organs), without local recurrence of nasopharynx. Completion of radiotherapy 4-12 weeks prior to enrollment. At list one cycle of adjuvant platinum-based chemotherapy. Satisfactory performance status: Karnofsky scale (KPS) > 70. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL. Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN. Adequate renal function: creatinine clearance ≥50 ml/min. Expected lifetime over 3 months Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: Previous history of autoimmune disease or unstable autoimmune disease. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections are not excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome are not excluded from the study. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Central Contact Person:

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

Jian Guan, Ph.D.

Phone

+86-13632102247

51643930@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Guan, Ph.D.

Organizational Affiliation

Nanfang Hospital, Southern Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Southern medical university

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Guan, M.D.

Phone

86+13632102247

guanjian5461@163.com

First Name & Middle Initial & Last Name & Degree

Jian Guan, M.D.

12. IPD Sharing Statement

Learn more about this trial

Camrelizumab After Completion of Radiotherapy for Oligometastatic Nasopharyngeal Carcinoma

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