Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma

NCT05128201 | Recruiting Phase 2

• 2 other identifiers: NPC-CR012020-PT320-004
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to explore the efficacy and tolerance of local consolidative radiotherapy combined with Camrelizumab and chemotherapy in patients with oligometastatic nasopharyngeal carcinoma

Conditions

Oligometastatic Disease

Keywords

local consolidative radiotherapy; oligometastatic nasopharyngeal carcinoma; Progression-free survival; immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The time from the start of treatment to the first observation of disease progression or death from any cause (whichever occurs first)

  2 years

Secondary Outcomes (4)

• Objective response rate (ORR)

  2 years

• Disease control rate (DCR)

  2 years

• Overall survival (OS)

  3 years

• Duration of Overall Response (DOR)

  2 years

Study Arms (1)

System treatment plus consolidative radiotherapy and Maintenance treatment

EXPERIMENTAL

4-6 Cycles System chemotherapy (Camrelizumab , Gemcitabine and cisplatin or nedaplatin) ; And local consolidative radiotherapy for all metastatic lesion (30-45Gy/3-8F) and Maintenance of Camrelizumab (total 2 years; from first cycles of System chemotherapy to last cycles of miantenance of camrelizumab)

Radiation: consolidative radiotherapy

Interventions

consolidative radiotherapy RADIATION

local consolidative radiotherapy for all metastatic lesion (30-45Gy/3-8F)

Also known as: local consolidative radiotherapy

System treatment plus consolidative radiotherapy and Maintenance treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 18-70 years old, no gender limit;
• \. Oligo metastasis is defined as less than or equal to 5 metastatic lesions and less than or equal to 2 metastatic organs
• \. Patients with an ECOG score of 0 or 1, and an expected survival period of ≥6 months;
• \. Has good organ function:
• Hematology: WBC\>3.0×109/L; ANC\>1.5×109/L; Hb\>90g/L; PLT\>100×109/L; Albumin ≥3g/dL;
• Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert disease and serum bilirubin level ≤ 3 times ULN can be included), AST and ALT ≤ 3 times ULN (if liver metastases occur , Then AST/ALT≤5 times ULN), and alkaline phosphatase≤3 times ULN (if liver or bone metastasis occurs, ALP≤5 times ULN); （3） Coagulation function: International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; （4）Renal function: According to the Cockcroft-Gault formula (Appendix 8), serum creatinine ≤1.5 times ULN or creatinine clearance ≥60mL/min.
• \. Female subjects have a negative pregnancy test (for female patients with fertility); female patients without fertility;
• \. Male patients with fertility and female patients with fertility and risk of pregnancy must agree to take adequate contraceptive measures throughout the study period, and contraception lasts for 12 months after receiving this program.
• \. Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests and other research procedures;
• \. During the research period, they are willing to comply with the arrangement and cannot participate in any other clinical research on drugs and medical devices;
• \. For patients who have previously received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or radiotherapy for non-metastatic diseases, the time from the last chemotherapy and/or radiotherapy to randomization must reach a non-treatment interval of ≥ 6 months . Oral S1 and capecitabine have no requirement for treatment interval for those who are progressing during chemotherapy.
• \. The patients sign a formal informed consent form to show that they understand that this study complies with the hospital's policies

You may not qualify if:

• \. Those who have a history of severe immediate hypersensitivity to any of the drugs used in this study;
• \. Suffered from other malignant tumors other than nasopharyngeal carcinoma within 5 years (except for tumors with an expected 5-year OS\>90%, such as non-melanoma skin cancer or pre-invasive cervical cancer);
• \. Any of the following conditions in the 6 months before screening: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient cerebral ischemia Onset or symptomatic pulmonary embolism. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria, or left ventricular ejection fraction \<50% must adopt an optimized and stable medical plan determined by the treating doctor. If appropriate, you can consult a cardiologist;
• \. Have received any of the following treatments:
• Have received anti-PD-1 or anti-PD-L1 antibody therapy in the past;
• Have received any investigational drug within 4 weeks before using the investigational drug for the first time;
• A large number of glucocorticoids or other immunosuppressants (including but not limited to prednisone, dexamethasone, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor) have been used in the 4 weeks before treatment Subjects with anti-TNF drugs, or subjects in need of hormone therapy during clinical trials. Other special circumstances require communication with the sponsor. In the absence of active autoimmune diseases, inhaled or topical steroids and adrenal cortex hormones with a dose\> 10 mg/day of prednisone are allowed to be substituted;
• Those who have been vaccinated with anti-tumor vaccines or the study drug has been vaccinated with live vaccines within 4 weeks before the first administration;
• Have undergone major surgery or severe trauma within 4 weeks before using the study drug for the first time;
• Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up;
• \. Patients with active autoimmune disease or a history of autoimmune disease but may relapse. Remarks: Patients with the following diseases are not excluded and can enter further screening:
• Controlled type 1 diabetes
• Hypothyroidism (if only hormone replacement therapy can be used to control)
• Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, hair loss)
• Any other diseases that are not expected to recur without external triggers

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Study Sites (3)

Fujian Cancer Hospital

Fuzhou, Fujian, 350011, China

RECRUITING

Ganzhou Cancer Hospital

Ganzhou, Jiangxi, China

RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: System chemotherapy (Camrelizumab , Gemcitabine and cisplatin or nedaplatin) And local consolidative radiotherapy for all metastatic lesion, and Maintenance of Camrelizumab

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: November 19, 2021
• Study Start: December 1, 2021
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)