Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Immunomodulating Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Antimetabolites

Patients were treated with gemcitabine, cisplatin and camrelizumab for 6 cycles, followed by whole-target radiotherapy (IMRT for locoregional lesion and SBRT for oligometastatic lesions) and camrelizumab maintenance therapy.

Patients receive gemcitabine (1000 mg/m² d1,8), cisplatin (80mg/m² d1), and camrelizumab (200mg, iv drip for over 60min) every 3 weeks for 6 cycles before locoregional radiotherapy.

Camrelizumab, gemcitabin, cisplatin

IMRT: 5 fractions per week for 6 weeks to a total dose of 70 Gy and 33 fractions to the primary tumor.

SBRT: 3 months after locoregional IMRT, patients receive SBRT for all oligometastatic lesions as radical therapy to control the disease and reduce any potential adverse impact to living quality. The dosage is based on published clinical studies.

Camrelizumab (200mg, iv drip for over 60min) every 2 weeks began on the first day of IMRT until an intolerable toxicity, or disease progression, or withdrawal of consent, or the investigator determines that he or she has to withdraw from treatment, or has been treated for up to 2 years.

Stereotactic Body Radiotherapy, Intensity modulated-radiotherapy

Ming-Yuan Chen, MD, PhD

Rui You, MD, PhD

Ming-Yuan Chen, MD,PhD

In this exploratory clinical trial, patients with newly diagnosed distant metastatic nasopharyngeal carcinoma were treated with gemcitabine+ cisplatin+PD-1 inhibitor regimen followed by whole-target radiotherapy (IMRT for local regional lesion, SBRT for distant metastasis) and PD-1 inhibitor long-term maintenance regimen. To investigate the efficacy and safety of "whole target" radiotherapy combined with immuno-maintenance therapy.

This exploratory clinical trial will evaluate tumor control rate, survival, and safety of newly diagnosed distant metastatic nasopharyngeal carcinoma by further adding local regional IMRT, distant metastatic SBRT and immuno-maintenance therapy to the standard regimen of gemcitabine+ cisplatin+ PD-1 inhibitor (historical data). To explore whether the "full target" model can be a better comprehensive therapy for the initial diagnosed distant metastatic nasopharyngeal carcinoma in the era of immunotherapy.

Whole-target Consolidation Therapy Under Systemic Therapy for Oligometastatic Nasopharyngeal Carcinoma

Whole-target Consolidation Therapy After Standard Chemotherapy for Initial Diagnosed Distant Metastatic Nasopharyngeal Carcinoma Under Full-course Immunotherapy: An Open-Label, Single Center, Nonrandomized, Phase 2 Study

Progression-free survival is calculated from the date of randomization to the date of death of any cause or the first progress at any site, censored on the last date of tumor evaluation if no progress has happened.

Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention.

Disease control rate is the rate of patients achieving complete response, partial response or stable disease for at least 4 weeks after intervention.

Overall survival is calculated from the date of randomization to the date of death of any cause, censored on the last date of known survival if no death has happened

NCI-CTC5.0 and RTOG standards are adopted, and acute subjective toxicity, acute objective toxicity and late subjective toxicity are included.

Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, and after treatment.

Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.

Defined as the time from first documentation of objective response to radiological disease progression.

Sun Yat-sen University

professor & chief physician

Symptoms and General Pathology

Disease Progression

Nedaplatin

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)

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

consolidative radiotherapy

Shaojun Lin, MD

Qiaojuan Guo, PhD

Wei Wu, MD

Jingao Li, MD

Xiaochang Gong, MD

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

This trial was a single-arm, multicenter phase Ⅱ clinical study. Eligible oligometastatic NPC patients were scheduled to evaluate the efficacy and tolerance of local consolidative radiotherapy combined with camrelizumab and chemotherapy in patients with oligometastatic NPC. Progression-free survival (PFS) determined will be the primary outcome measures.

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

Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma

Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma: A Multicenter, Open-Label, Phase II Trial (NPC-CR01)

After completing the treatment plan, we will report our research plan and research results.

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

the proportion of patients achieving the optimal overall remission (complete or partial remission)

the proportion of patients with the best efficacy (CR or PR or SD)

the time from the start of treatment to death from any cause

the time the patient first reaches complete or partial remission to disease progression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Whole-target Consolidation Therapy Under Systemic Therapy for Oligometastatic Nasopharyngeal Carcinoma	NCT05431764	Nasopharyngeal ...	Camrelizumab, g... Stereotactic Bo...	18 Years - 70 Years	Sun Yat-sen University
Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma	NCT05128201	Oligometastatic...	consolidative r...	18 Years - 70 Years	Jiangxi Provincial Cancer Hospital
Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma	NCT05128201	Oligometastatic...	consolidative r...	18 Years - 70 Years	Jiangxi Provincial Cancer Hospital
Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma	NCT05128201	Oligometastatic...	consolidative r...	18 Years - 70 Years	Jiangxi Provincial Cancer Hospital

Spots Global Cancer Trial Database for oligometastatic nasopharyngeal carcinoma