Status:
UNKNOWN
Induction Chemotherapy and Toripalimab Followed by Radiotherapy in Unresectable Laryngeal/Hypopharyngeal Carcinoma
Lead Sponsor:
Fudan University
Conditions:
Laryngeal Cancer
Hypopharyngeal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 unresect...
Detailed Description
Historically, induction chemotherapy has been shown to increase laryngeal-preservation rate, improve disease-free survival and reduce the risk of distant metastasis. However, the prognosis of locally ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT05420597
Start Date
April 7 2021
End Date
December 31 2025
Last Update
June 15 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032