Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial

NCT05340491 | Recruiting Phase 3 DMC

• 1 other identifier: B2022-111-01
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 12

Brief Summary

This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.

Conditions

Nasopharyngeal Carcinoma

Keywords

locoregional relapse; nasopharyngeal carcinoma; chemoradiotherapy; PD-1 antibody; efficacy; toxicity

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Defined as the time from date of recruitment to death from any cause.

  three years

Secondary Outcomes (7)

• Failure-free survival

  three years

• Objective response rate through study completion, an average of nine months

  through study completion, an average of nine months

• Disease control rate through study completion, an average of nine months

  through study completion, an average of nine months

• Incidence of nasopharyngeal necrosis and hemorrhage up to 3 years

  up to three-year follow-up

• Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0)

  through study completion, an average of nine months

Study Arms (2)

Chemoradiotherapy+anti-PD-1

EXPERIMENTAL

Patients in this arm will receive three cycles of GP chemotherapy plus PD-1 antibody, then receive IMRT and PD-1 antibody maintenance for eight cycles.

Drug: Toripalimab; Drug: Chemotherapy; Radiation: Intensity modulated radiotherapy

Chemoradiotherapy

ACTIVE COMPARATOR

Patients in this arm will receive three cycles of GP chemotherapy, then receive IMRT.

Drug: Chemotherapy; Radiation: Intensity modulated radiotherapy

Interventions

Toripalimab DRUG

240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT

Also known as: JS001

Chemoradiotherapy+anti-PD-1

Chemotherapy DRUG

Gemcitabine: 1.0g/m2, D1 and D8, Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles

Also known as: GP

Chemoradiotherapy; Chemoradiotherapy+anti-PD-1

Intensity modulated radiotherapy RADIATION

total 60-66Gy, 1.8-2.0Gy/f/day

Also known as: IMRT

Chemoradiotherapy; Chemoradiotherapy+anti-PD-1

Eligibility Criteria

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

You may qualify if:

• Diagnosed as local with or without regional recurrence after ≥1 year of radical treatment;
• Not suitable for surgery;
• Histologic diagnosis of NPC (WHO II/III);
• TNM stage rII-IVa (AJCC/UICC 8th);
• ECOG 0-1 point;
• No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
• No contraindications to immunotherapy or chemoradiotherapy;
• Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
• Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
• Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
• Take effective contraceptions during and two months after treatment;
• Patients must be informed of the investigational nature of this study and give written informed consent.

You may not qualify if:

• Treated with anti-tumor Chinese medicine treatment;
• Have recurrence with local necrosis;
• Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
• Unexplained fever \> 38.5, except for tumor fever;
• Treated with ≥ 5 days antibiotics one month before enrollment;
• Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive; Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
• Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
• Have known allergy to large molecule protein products or any compound of study therapy;
• Pregnant or breastfeeding;
• Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
• Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
• Any other condition, including 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

• Sun Yat-sen University: lead

Study Sites (12)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Peking University Third Hospital

Beijing, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, China

NOT YET RECRUITING

Fujian Province Cancer Hospital

Fuzhou, China

NOT YET RECRUITING

Guizhou Cancer Hospital

Guiyang, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, China

RECRUITING

Jiangxi Cancer Hospital

Nanchang, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

NOT YET RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, China

RECRUITING

Xijing Hospital

Xi'an, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, China

NOT YET RECRUITING

Related Links

• Home Page of Sun Yat-sen University Cancer Center

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

toripalimab; Drug Therapy; 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)

Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy

Study Officials

• Chong Zhao, MD PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingjing Miao, PhD

CONTACT

+8613631355201; miaojj@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: April 22, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

CN (12)