Clinical trial · Interventional
Induction Chemotherapy and Toripalimab Followed by Radiotherapy in Unresectable Laryngeal/Hypopharyngeal Carcinoma
NCT05420597CI-TRIAL-00059087unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) followed by radiotherapy improve progression-free survival, for patients with unresectable laryngeal/hypopharyngeal carcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypopharyngeal Cancer | Malignant Hypopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Laryngeal Cancer | Malignant Laryngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction chemotherapy and Toripalimab
- description
- Induction chemotherapy TP regimen combined with Toripalimab, followed by cisplatin-based concurrent chemoradiation.
- interventionNames
- Drug: Toripalimab
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 2 year
- description
- From the rate of enrollment to first progression
Secondary outcomes (6)
- measure
- Overall response rate of induction chemotherapy
- timeFrame
- up to 3 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed, unresectable locally advanced laryngeal/hypopharyngeal squamous cell carcinoma due to extensively local invasion or medical comorbidities (T3-4b, N0-N3, M0); * Age between 18-75 years; * Signed inform consent; * Had at least one measurable lesion according to RECIST 1.1 criteria * Anticipated overall survival more than 3 months; * Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1; * Normal organ function and bone marrow function; * HBV DNA\<500 IU/mL（or 2500 copies/mL）and HCV RNA negative ; * Male and no pregnant female, able to adapt birth control methods during treatment. Exclusion Criteria: * Hypersensitivity to Toripalimab, Paclitaxel or Cisplatin; * Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years; * Severe, uncontrolled heart disease; * Receive vaccine or live vaccine within 28 days prior to signing the informed consent; * Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent; * Surgery or trauma within 28 days prior to signing the informed consent; * Received other immune checkpoint inhibitors previously; * Severe, uncontrolled infections within 28 days of prior to signing the informed consent; * Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, vitiligo or inactive asthma who don't need systemic therapy can recruit; * History of interstitial lung disease; * HIV positive; * Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA; * Other diseases which may influence the safety or compliance of the clinical trial, such as mental illness, or their family and society factors; * Women of child-bearing potential who are pregnant or breastfeeding.
References
Publications (0)
Data not yet available
No reference posted for this study.