Camrelizumab for the Treatment of Locally Advanced Nasopharyngeal Carcinoma

NCT05097209 | Recruiting Phase 2

• 1 other identifier: GLMU-07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

Brief Summary

This trial plans to enroll patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients will be randomized in a 1:1 ratio to receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation or 3 cycles of induction chemotherapy with gemcitabine and cisplatin and radiation plus Camrelizumab. All patients will receive intensity-modulated radiotherapy (IMRT). Camrelizumab will begin on day 1 of induction chemotherapy every 3 weeks for 3 cycles and continue every 2 weeks for 9 cycles.

Conditions

Nasopharyngeal Carcinoma

Keywords

Intensity Modulated Radiotherapy; Camrelizumab

Outcome Measures

Primary Outcomes (1)

• Progress-free survival (PFS)

  Calculated from randomization to the date of progression or death from any cause, whichever occurred first.

  3 years

Secondary Outcomes (4)

• Overall survival (OS)

  3 years

• Distant Metastasis-free survival (DMFS)

  3 years

• Locoregional failure-free survival (LRRFS)

  3 years

• Adverse events (AEs) and serious adverse events (SAEs)

  3 years

Study Arms (2)

Camrelizumab arm

EXPERIMENTAL

Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter.

Drug: Camrelizumab; Drug: Gemcitabine; Drug: Induction Cisplatin; Radiation: intensity-modulated radiotherapy

Chemoradiation arm

ACTIVE COMPARATOR

Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT.

Drug: Gemcitabine; Drug: Induction Cisplatin; Radiation: intensity-modulated radiotherapy; Drug: Concurrent cisplatin

Interventions

Camrelizumab DRUG

Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter.

Also known as: PD-1 antibody

Camrelizumab arm

Gemcitabine DRUG

Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation

Also known as: Gem

Camrelizumab arm; Chemoradiation arm

Induction Cisplatin DRUG

Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation

Also known as: DDP

Camrelizumab arm; Chemoradiation arm

intensity-modulated radiotherapy RADIATION

Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.

Also known as: IMRT

Camrelizumab arm; Chemoradiation arm

Concurrent cisplatin DRUG

Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation

Also known as: DDP

Chemoradiation arm

Eligibility Criteria

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

You may qualify if:

• Patients with histologically confirmed nasopharyngeal carcinoma.
• Tumor staged as III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0).
• Eastern Cooperative Oncology Group performance status ≤1.
• Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥80g/L and platelet count ≥80×10e9/L.
• Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
• Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
• Patients must be informed of the investigational nature of this study and give written informed consent.
• Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.

You may not qualify if:

• Age \> 70 or \< 18.
• Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA \>1×10e3 copies/ml or 200IU/ml
• Hepatitis C virus (HCV) antibody positive
• Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
• Has any condition that required systemic corticosteroid (equivalent to prednisone \>10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed.
• Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed.
• Has a known history of interstitial lung disease.
• Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
• Is pregnant or breastfeeding.
• Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
• Has known allergy to large molecule protein products or any compound of camrelizumab.
• Has a known history of human immunodeficiency virus (HIV) infection.
• Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.

Sponsors & Collaborators

• Wei Jiang: lead
• Wuzhou Red Cross Hospital: collaborator
• Guangxi Nanxishan Hospital: collaborator
• Laibin People's Hospital: collaborator
• Lingshan people's Hospital: collaborator

Study Sites (5)

Guangxi Nanxishan hospital

Guilin, Guangxi, China

RECRUITING

Guilin Medical University

Guilin, Guangxi, China

RECRUITING

Laibin People's Hospital

Laibin, Guangxi, China

RECRUITING

Linshan people's hospital

Linshan, Guangxi, China

RECRUITING

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

NOT YET RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

camrelizumab; spartalizumab; Gemcitabine; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Bin Zhang, M.D.

  Wuzhou Red Cross Hospital

  PRINCIPAL INVESTIGATOR

• Yu-fei Pan, M.D.

  Guangxi Nanxishan Hospital

  PRINCIPAL INVESTIGATOR

• Yi-xin Su, M.D.

  Lingshan people's Hospital

  PRINCIPAL INVESTIGATOR

• Jian Zhang, M.D.

  Laibin People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Jiang, Ph.D.

CONTACT

+86-773-2882906; weijiang@glmc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Radiation Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 28, 2021
• Study Start: April 6, 2022
• Primary Completion: April 6, 2025
• Study Completion: April 6, 2026
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)