Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| De-escalation | — | UNRESOLVED | — |
| Immune Checkpoint Inhibitor | — | UNRESOLVED | — |
| Oropharyngeal Carcinoma | Oropharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Toxicities reduced treatment arm | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- conventional treatment arm
- description
- 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)
- interventionNames
- Other: Toxicities reduced treatment arm
Primary outcomes (1)
- measure
- PFS PFS
- timeFrame
- 2 year
- description
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available