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NCT06156891
PD-1 Inhibitor Based Induction Chemotherapy Followed by De-escalation Protocols in OPSCC
Phase 2 trial testing Toxicities reduced treatment in Oropharyngeal Cancer in 60 participants. Status unknown.
30 July 2025
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 29 June 2022 |
| Primary completion | 30 July 2025 |
| Estimated completion | 30 July 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Toxicities reduced treatment
- Conventional treatment — full drug profile →
Conditions studied
- Oropharyngeal Cancer — all drugs for Oropharyngeal Cancer →
Sponsor
Fudan University
Who can join
Adults 18 to 70, any sex, with Oropharyngeal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
More and more studies have shown that the efficacy and prognosis of HPV （Human papillomavirus）-positive oropharyngeal cancer (OPC) patients are better than those of others. However, in the NCCN (National Comprehensive Cancer Network) Oncology Clinical Guidelines for OPC treatment, each group of p16+ is consistent with the corresponding group of p16-, which indicates that the treatment of OPC is basically the same regardless of whether it is related to HPV. Several studies attempted to reduce the toxicities of treatment of HPV related OPC through reduced-dose radiation and showed promising results, and all of the studies have shown that induction chemotherapy is a good way to screen followed treatment. Those who are effective in induction chemotherapy are usually more sensitive to radiation therapy, and reducing the intensity of subsequent treatment will not affect the survival outcome of patients. Immune checkpoint inhibitors (ICIs) have proved to improve outcomes of head and neck cancers. However, In KEYMAT-048, a Phase III controlled trial of relapsed/metastatic head and neck squamous cell carcinoma, ICIs showed an overall survival advantage, but the survival advantage was independent of HPV status. Therefore, patients with HPV-negative OPC still have a good response to ICIs. So we added anti-PD-1 antibody Toripalimab to induction chemotherapy in order to achieve better response rates to receive de-escalation chemoradiotherapy followed regardless of whether it is related to HPV.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other trials of Toxicities reduced treatment
Trials testing the same drug.
- NCT04158518 — De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma · NA · unknown
- NCT04012502 — De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations · NA · unknown
Other recruiting trials for Oropharyngeal Cancer
Currently open trials in the same condition.
- NCT07209189 — Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-esca · Phase 2 · recruiting
- NCT06446713 — PIRATES: Image-guided Hyper-fractioned Dose-escalation With Proton Therapy for Head and Neck Cancer · Phase 1 · recruiting
- NCT06747390 — Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery · Phase 1 · recruiting
- NCT05363709 — BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients · Phase 2 · active not recruiting
- NCT05862792 — Liposomal Bupivacaine and Transoral Robotic Surgery · recruiting
Other Fudan University trials
Trials by the same sponsor.
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- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06156891 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fudan University
- Last refreshed: 5 December 2023
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