PACIFIC-NPC: PD-1 Antibody Versus Best Supportive Care After Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03427827
• Collaborator: (none)
• Enrollment: 442
• Locations: 11
• Arms: 2
• Anticipated Duration (Months): 91
• Patients Per Site: 40.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This trial is aimed to investigate whether adjuvant PD-1 antibody treatment could improve survival in locoregionally advanced nasopharyngeal carcinoma compared to best supportive care.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Neoplasms	Drug: Camrelizumab	Phase 3

Detailed Description

In this multicenter, randomised controlled, phase 3 trial, patients with stage III-IVA (AJCC/UICC 8th system, except T3-4N0 and T3N1) non-metastatic nasopharyngeal carcinoma will be randomized in a 1:1 ratio to recieve PD-1 antibody for 12 doses every 3 weeks or best supportive care after curative chemoradiation.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 442 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Camrelizumab (PD-1 Antibody) Compared With Best Supportive Care After Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Multi-center, Randomised Controlled, Phase 3 Trial (PACIFIC-NPC)
• Actual Study Start Date: Jul 2, 2018
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adjuvant PD-1 antibody arm Patients randomized to this arm will receive PD-1 antibody (SHR-1210), 200mg, ivdrip (>30 minutes), d1, q3w × 12 cycles, begining at 4-6 weeks after chemoradiation	Drug: Camrelizumab; Camrelizumab is an antibody targeting PD-1 developed by Jiangsu Hengrui Medicine, China.; Other Names: SHR-1210
No Intervention: Best supportive care Patients randomized to this arm will receive best supportive care after chemoradiation

Outcome Measures

Primary Outcome Measures

1. failure-free survival [3 years]

   calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.

Secondary Outcome Measures

1. overall survival [5 years]

   calculated from date of randomisation to death

2. distant metastasis-free survival [3 years]

   calculated from date of randomisation to the first distant failure

3. locoregional recurrence-free survival [3 years]

   calculated from date of randomisation to the first locoregional failure

4. adverse events (AEs) and severe adverse events (SAE) [3 years]

   graded according to NCI CTCAE v5.0

5. quality of life (QoL) [3 years]

   the change of QoL from randomization to 36 months after chemoradiation, graded according to EORTC QLQ-C30 V3.0

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with histologically confirmed nasopharyngeal carcinoma.

• Tumor staged as III-IVA (AJCC 8th, except T3N0-1 or T4N0).

• Completed protocol-specified curative chemoradiotherapy, including gemcitabine and cisplatin induction chemotherapy, intensity-modulated radiotherapy, and concurrent cisplatin chemotherapy.

• Completion of the last radiation dose within 1 to 14 days before randomization

• Eastern Cooperative Oncology Group performance status ≤1.

• Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/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.

Exclusion Criteria:

• Age > 65 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First People's Hospital of Foshan	Foshan	Guangdong	China
2	Guangzhou Medical University Cancer Hospital	Guangzhou	Guangdong	China	510060
3	Panyu central hospital	Guangzhou	Guangdong	China	510060
4	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060
5	Cancer Hospital of Guangxi Medical University	Nanning	Guangxi	China
6	Cancer Hospital of Guizhou Medical University	Guiyang	Guizhou	China
7	Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei	China
8	Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei	China
9	Xiangya Hospital Central South University	Changsha	Hunan	China
10	Xijing Hospital, Fourth Military Medical University	Xi'an	Shanxi	China
11	West China Hospital, Sichuan University	Chengdu	Sichuan	China

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

• Principal Investigator: Jun Ma, MD, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jun Ma, MD, Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT03427827
• Other Study ID Numbers: B2017-097-01
• First Posted: Feb 9, 2018
• Last Update Posted: May 9, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jun Ma, MD, Professor, Sun Yat-sen University: PD-1 antibody; Adjuvant treatment; Immune checkpoint inhibitors
• Additional relevant MeSH terms: Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms

Study Results

No Results Posted as of May 9, 2022