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

Induction Chemotherapy of Toripalimab With Docetaxel and Cisplatin Followed by De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04867330
Enrollment
46
Registered
2021-04-30
Start date
2021-02-01
Completion date
2026-01-31
Last updated
2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

De-escalation, Immune Checkpoint Inhibitor, Oropharyngeal Carcinoma

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.

Interventions

OTHERToxicities reduced treatment arm

Two cycles Toripalimab+docetaxel+cisplatin induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
PFS PFS2 yearProgression Free Survival

Countries

China

Contacts

Primary ContactChaosu Hu, MD
hucsu62@163.com+8618017312903

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026