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Carbon-Ion Radiotherapy Plus Camrelizumab for Locally Recurrent Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Induction chemotherapy

Carbon-ion radiotherapy

Camrelizumab

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Completed a definitive course of intensity-modulated photon radiation therapy (IMRT) to a total dose of ≥ 66 Gy
Recurrence at nasopharynx diagnosed more than 6 months after the initial course of IMRT
Patients with neck lymphadenopathy should receive neck dissection before randomization
With measurable lesion on contrast MR scan
Age ≥ 18 and < 70 years of age
ECOG score: 0-1
Leucocyte count ≥ 4000/µL, neutrocyte count ≥ 2000/µL, platelet count ≥ 100000/µL, hemoglobin ≥ 90g/L
Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) < 1.5×upper limit of normal (ULN), alkaline phosphatase < 2.5×ULN, bilirubin ≤ ULN, serum creatinine ≤ ULN, creatinine clearance ≥ 60ml/min
Willing to accept adequate contraception
Ability to understand the nature of the clinical trial and sign the written informed consent

Exclusion Criteria:

Presence of distant metastasis
Previously received radioactive particle implantation
Prior malignancy within 5 years before randomization, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer
Patients who received local (such as surgery and cryotherapy) or systemic treatment, except for induction chemotherapy after diagnosis of recurrence
With uncontrolled active infection
With pneumonia
With autoimmune disease
With a known history of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
Hepatitis B virus (HBV) DNA ≥ 500IU/mL for patients with positive HBV surface antigen, positive hepatitis C virus RNA for patients with positive HCV antigen
Previously treated by immune checkpoint inhibitors
Medical conditions requiring treatment of antibiotics and/or corticosteroid
Treated with ≥ 5 days antibiotics one month before start of immunotherapy
With known allergy to any of the study drugs
Pregnant or lactating women
Any severe intercurrent disease that may interfere with the current study

Sites / Locations

Shanghai Proton and Heavy Ion CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm-C

Arm-CC

Arm Description

Patients will receive induction chemotherapy followed by carbon-ion radiotherapy with a dose of 63 GyE in 21 fractions (the fraction size is 3 GyE).

Patients will receive induction chemotherapy followed by carbon-ion radiotherapy and camrelizumab. In details, patients will receive carbon-ion radiotherapy with a dose of 63 GyE in 21 fractions (the fraction size is 3 GyE); in addition, patients will also receive camrelizumab of 200 mg (IV.), every 2 weeks, started with carbon-ion radiotherapy for a maximal period of 1 year.

Outcomes

Primary Outcome Measures

Progression-free survival

Duration from randomization to documented disease recurrence or death from any cause, whichever occurs first.

Secondary Outcome Measures

Overall survival

Duration from randomization to death from any cause.

Local progression-free survival

Duration from randomization to documented local recurrence or death from any cause, whichever occurs first.

Regional progression-free survival

Duration from randomization to documented regional recurrence or death from any cause, whichever occurs first.

Distant metastasis-free survival

Duration from randomization to documented distant metastasis or death from any cause, whichever occurs first.

Number of participants with adverse events

Incidence of adverse events

Full Information

NCT ID

NCT04143984

First Posted

October 27, 2019

Last Updated

April 24, 2022

Sponsor

Shanghai Proton and Heavy Ion Center

1. Study Identification

Unique Protocol Identification Number

NCT04143984

Brief Title

Carbon-Ion Radiotherapy Plus Camrelizumab for Locally Recurrent Nasopharyngeal Carcinoma

Official Title

A Phase 2 Randomized Clinical Trial to Examine the Efficacy of Carbon-Ion Radiotherapy Plus Camrelizumab As Salvage Treatment for Locally Recurrent Nasopharyngeal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 19, 2021 (Actual)

Primary Completion Date

December 20, 2025 (Anticipated)

Study Completion Date

December 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Proton and Heavy Ion Center

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

The purpose of this trial is to examine the role of camrezlizumab in addition to carbon-ion radiotherapy (CIRT) for patients with locally recurrent nasopharyngeal carcinoma. According to the plan, a total of 146 patients will be recruited and randomized into: 1) CIRT alone group (control group); 2) CIRT plus camrelizumab group (experimental group).

Detailed Description

Treatment for locally recurrent nasopharyngeal carcinoma (LR-NPC) is challenging. Carbon-ion radiotherapy appeared to be an effective treatment for this group of patients, and has substantially improved the 2-year overall survival (OS) to approximately 85%, compared to photon-based intensity-modulated radiotherapy. However, a group of the patients may still develop disease progression after CIRT, and the 2-year progression-free survival (PFS) was approximately 45%-50%. Camrelizumab, a programmed cell death 1 (PD-1) inhibitor, has been demonstrated that it is effective in the recurrent/metastatic nasopharyngeal carcinoma; however, the role of camrelizumab in concurrence with radiotherapy, especially CIRT, for LR-NPC is not clear. The purpose of this phase 2 clinical trial is to compare the efficacy of CIRT plus camrelizumab and CIRT alone in the treatment of LR-NPC. Eligible participants will be randomized (1:1) to 1) CIRT alone group (control group); 2) CIRT plus camrelizumab group (experimental group). The primary endpoint is progression-free survival. Secondary endpoints include overall survival (OS), local progression-free survival (LPFS), regional progression-free survival (RPFS), and distant metastasis-free survival (DMFS) and toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

6. Conditions and Keywords

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

Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm-C

Arm Type

Active Comparator

Arm Description

Patients will receive induction chemotherapy followed by carbon-ion radiotherapy with a dose of 63 GyE in 21 fractions (the fraction size is 3 GyE).

Arm Title

Arm-CC

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Induction chemotherapy

Intervention Description

Induction chemotherapy with the regimen of gemcitabine plus nedaplatin.

Intervention Type

Radiation

Intervention Name(s)

Carbon-ion radiotherapy

Intervention Description

Accelerated carbon-ion beam with pencil beam scanning technique.

Intervention Type

Drug

Intervention Name(s)

Camrelizumab

Other Intervention Name(s)

SHR-1210

Intervention Description

An anti-PD-1 antibody.

Primary Outcome Measure Information:

Title

Progression-free survival

Description

Duration from randomization to documented disease recurrence or death from any cause, whichever occurs first.

Time Frame

2-year

Secondary Outcome Measure Information:

Title

Overall survival

Description

Duration from randomization to death from any cause.

Time Frame

2-year

Title

Local progression-free survival

Description

Duration from randomization to documented local recurrence or death from any cause, whichever occurs first.

Time Frame

2-year

Title

Regional progression-free survival

Description

Duration from randomization to documented regional recurrence or death from any cause, whichever occurs first.

Time Frame

2-year

Title

Distant metastasis-free survival

Description

Duration from randomization to documented distant metastasis or death from any cause, whichever occurs first.

Time Frame

2-year

Title

Number of participants with adverse events

Description

Incidence of adverse events

Time Frame

2-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: Completed a definitive course of intensity-modulated photon radiation therapy (IMRT) to a total dose of ≥ 66 Gy Recurrence at nasopharynx diagnosed more than 6 months after the initial course of IMRT Patients with neck lymphadenopathy should receive neck dissection before randomization With measurable lesion on contrast MR scan Age ≥ 18 and < 70 years of age ECOG score: 0-1 Leucocyte count ≥ 4000/µL, neutrocyte count ≥ 2000/µL, platelet count ≥ 100000/µL, hemoglobin ≥ 90g/L Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) < 1.5×upper limit of normal (ULN), alkaline phosphatase < 2.5×ULN, bilirubin ≤ ULN, serum creatinine ≤ ULN, creatinine clearance ≥ 60ml/min Willing to accept adequate contraception Ability to understand the nature of the clinical trial and sign the written informed consent Exclusion Criteria: Presence of distant metastasis Previously received radioactive particle implantation Prior malignancy within 5 years before randomization, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer Patients who received local (such as surgery and cryotherapy) or systemic treatment, except for induction chemotherapy after diagnosis of recurrence With uncontrolled active infection With pneumonia With autoimmune disease With a known history of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) Hepatitis B virus (HBV) DNA ≥ 500IU/mL for patients with positive HBV surface antigen, positive hepatitis C virus RNA for patients with positive HCV antigen Previously treated by immune checkpoint inhibitors Medical conditions requiring treatment of antibiotics and/or corticosteroid Treated with ≥ 5 days antibiotics one month before start of immunotherapy With known allergy to any of the study drugs Pregnant or lactating women Any severe intercurrent disease that may interfere with the current study

Central Contact Person:

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

Jiyi Hu, MD, PhD

Phone

+8602138296666

Ext

53513

jiyi.hu@sphic.org.cn

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

Lin Kong, MD

Phone

+8602138296666

Ext

53516

konglin@sphic.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiade J Lu, MD

Organizational Affiliation

Shanghai Proton and Heavy Ion Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Proton and Heavy Ion Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201315

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiyi Hu, MD, PhD

Phone

+8602138296666

Ext

53513

jiyi.hu@sphic.org.cn

First Name & Middle Initial & Last Name & Degree

Lin Kong, MD

Phone

+8602138296666

Ext

53516

konglin@sphic.org.cn

First Name & Middle Initial & Last Name & Degree

Jiade J Lu, MD

First Name & Middle Initial & Last Name & Degree

Lin Kong, MD

First Name & Middle Initial & Last Name & Degree

Jiyi Hu, MD, PhD

First Name & Middle Initial & Last Name & Degree

Weixu Hu, MD

First Name & Middle Initial & Last Name & Degree

Jing Yang, MD

First Name & Middle Initial & Last Name & Degree

Jing Gao, MD

First Name & Middle Initial & Last Name & Degree

Xianxin Qiu, MD

First Name & Middle Initial & Last Name & Degree

Qingting Huang, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data on participants' clinical features, treatment modalities, survivals and toxicity profile will be shared upon reasonable request. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.

IPD Sharing Time Frame

Within 3 years after publication of the study.

IPD Sharing Access Criteria

Data mentioned in the plan description and relevant supporting files will be shared with radiation oncologist who are interested in conducting pooled analysis comparing carbon-ion radiotherapy with other treatment modalities (such as other radiation technique and systemic therapy) for patients with recurrent nasopharyngeal carcinoma. The IPD will only be shared after the study protocol is reviewed and approved by the principle investigator.

Learn more about this trial

Carbon-Ion Radiotherapy Plus Camrelizumab for Locally Recurrent Nasopharyngeal Carcinoma

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