Toripalimab Based Induction Chemotherapy Followed by De-escalation Protocols in HPV-related OPSCC

Not Applicable

Recruiting

• Conditions: De-escalation; Immune Checkpoint Inhibitor; Oropharyngeal Carcinoma
• Interventions: Other: Toxicities reduced treatment arm

• Registration Number: NCT04867330
• Lead Sponsor: Fudan University

Brief Summary

Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma (NPC), oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma. Immune checkpoint inhibitors (ICIs) have proved to improve outcomes of head and neck cancers including EBV-related NPC. Oropharyngeal carcinoma was considered to be similar with NPC in terms of immune environment. So we added anti-PD-1 antibody Toripalimab to induction chemotherapy in order to achieve better response rates to receive de-escalation chemoradiotherapy followed.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Last Update Submitted: 2021-04-27
• Study First Posted: 2021-04-30
• Last Update Posted: 2021-04-30
• Primary Completion: 2021-05
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16
• positive or PCR HPV16 positive
• T1-2/N1-3M0（except T1N1M0 and single LN<3cm）or T3-4N0-3M0 according to UICC/AJCC 8th staging system
• Age ≥18
• No prior anti-tumor treatment
• Karnofsky Performance Score (KPS)≥70
• Adequate blood supply
• Informed consent obtained

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Exclusion Criteria

• Cannot take contrast-MRI imaging
• Pregnant
• Combined with other malignant tumor (except basal cell carcinoma of skin)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
conventional treatment arm	Toxicities reduced treatment arm	Two cycles Toripalimab+docetaxel+cisplatin induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)

Primary Outcome Measures

Name	Time	Method
PFS PFS	2 year	Progression Free Survival

Trial Locations

Locations (1)

Fudan Universtiy Shanghai Cancer Centre; 🇨🇳 Shanghai, China