Programmed Death-1 (PD-1) Antibody Combined With Chemoradiotherapy in High-risk Recurrent Nasopharyngeal Carcinoma

Phase 2

Active, not recruiting

• Conditions: Recurrent Nasopharyngeal Carcinoma
• Interventions: Drug: PD-1 blocking antibody; Drug: Chemotherapy; Radiation: IMRT

• Registration Number: NCT03930498
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This is a a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-29
• Study Start: 2020-03-12
• Primary Completion: 2023-11-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-28
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
• Not suitable for surgery;
• Newly histologic diagnosis of NPC (WHO II/III);
• Clinical stage rII-IVa (AJCC/UICC 8th);
• ECOG 0-1 point;
• PRANCIS score > 252 points;
• No treatment to rNPC, 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-1 antibody plus chemoradiotherapy	PD-1 blocking antibody	-
PD-1 antibody plus chemoradiotherapy	Chemotherapy	-
PD-1 antibody plus chemoradiotherapy	IMRT	-

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years	From date of recruitment to death

Secondary Outcome Measures

Name	Time	Method
Objective response rate	After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days)	Patient's short-term effect
Progression free survival	2 years	From date of recruitment to disease progression or death
Disease control rate	After 3 cycles of GP chemothrapy plus PD-1 antibody (each cycle is 21 days)	Patient's short-term effect
Adverse effects	through study completion, an average of 3 months	Evaluating with CTCAE v5.0
Quality of life: EuroQoL 5 dimension	through whole study, an average of 2 years	Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China