Clinical trial · Interventional
Toripalimab Plus TPF Chemotherapy and Radiotherapy for LA-HPSCC
Toripalimab Plus TPF Inductive Chemotherapy and Definitive Radiotherapy for Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, Efficacy and Safety: a Phase II Prospective Cohort Study
- 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)
TPF is the standard regime of inductive chemotherapy for squamous carcinoma of head and neck. If the primary tumor shrinks obviously (complete remission or \>75% partial remission )after inductive chemotherapy, CCRT is suggested as the definitive therapy, for the tumor is sensitive to chemotherapy. If the primary tumor shrinks a little or progresses after inductive chemotherapy, operation is suggested as the definitive therapy to get a longer survival.
Conditions
Conditions (1)
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 Neoplasm Malignant Primary | Hypopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TPF inductive chemotherapy plus Toripalimab and radiotherapy plus Toripalimab
- description
- TPF inductive chemotherapy plus Toripalimab for 3 cycles, and radiotherapy plus Toripalimab if the inductive treatment efficacy is CR or \>75%PR. If not, operation is suggested.
- interventionNames
- Drug: Toripalimab
Primary outcomes (1)
- measure
- Complete remission rate
- timeFrame
- 3 months after treatment
- description
- Complete remission rate 3 months after treatment
Secondary outcomes (4)
- measure
- ORR
- timeFrame
- 3 months after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria:
1. 18y ≤age≤65y;
2. ECOG：0-1；
3. Histology：squamous cell carcinoma, located in hypopharynx;
4. clinical stage: cT1N1-3M0、cT2-3N0-3M0，organ-preservation-intent regime is made after multidisciplinary treatment(MDT) discussion. Efficacy evaluation will be made according to RECIST 1.1 after inductive chemotherapy, and the following treatment will be chosen according to the results of efficacy evaluation.
5. never received any previous treatment, including radiotherapy, chemotherapy, or immune therapy, et al.
6. at least one measurable lesion (RECIST 1.1 criteria).
7. expected survival ≥6 months.
8. no contraindications of radiotherapy, chemotherapy and immune therapy.
9. functions of main organs A. WBC≥3.0x109 /L，ANC≥1.5x109/L B. HB≥90g/L C. PLT≥100x109 /L D. serum albumin≥2.8g/dL E. TBil ≤1.5xULN，ALT、AST≤3.0xULN F. serum creatinine ≤1.5xULN or creatinine clearance rate\>60mL/min（Cockcroft-Gault） G. APTT and INR ≤1.5xULN
10. contraception
11. voluntary and compliance.
Exclusion Criteria:
1. other histology cancers located in hypopharynx.
2. synchronous or metachronous cancers located in other sites.
3. allergy to monoclonal antibody.
4. uncontrollable heart disease or symptoms.
5. uncontrollable infections.
6. fever of unknown origin\>38.5℃ during screening or before administration.
7. active autoimmune disease.
8. history of immunodeficiency disorders, including HIV.
9. active HBV or HCV.
10. history of interstitial lung disease.
11. active tuberculosis.
12. received any drugs listed below: A. received any study drug 4 weeks before first dose of Toripalimab. B. received any anti-cancer drug 4 weeks before first dose of Toripalimab. C. received any glucocorticoids （\>10mg prednison per day） 2 weeks before first dose of Toripalimab.
D. received any cancer vaccine 4 weeks before first dose of Toripalimab. E. received any operation or trauma 4 weeks before first dose of Toripalimab. F. recruited in other study.
13. uncontrollable hypertension.
14. uncontrollable type 2 diabetes；
15. hemorrhagic tendency.
16. drug or alcoholic abuse.
17. woman during pregnancy or lactation period.References
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