A Phase 2 interventional study of three cycles (toripalimab + cetuximab + platinum) and Radical surgery in Locally Advanced Hypopharyngeal Carcinoma, sponsored by Eye & ENT Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Eye & ENT Hospital of Fudan University · Phase 2, Interventional, and Treatment
The purpose of this clinical trial is to evaluate the efficacy and safety of immunotherapy combined with cetuximab and platinum neoadjuvant therapy in patients with resectable locally advanced hypopharyngeal cancer. Participants will receive three cycles of TPC neoadjuvant therapy (toripalimab+ cetuximab + platinum), radical surgery (laryngeal preservation surgery if possible), and sequential (chemo)radiotherapy treatment after surgery. This trial aims to answer the following questions:
The standard treatment for patients with resectable hypopharyngeal carcinoma is surgery plus postoperative adjuvant radiotherapy or chemoradiotherapy. Growing evidence shows that neoadjuvant therapy may significantly increase pCR in locally advanced SCCHN patients, potentially improving patient survival. The development of drugs, immunotherapy, and targeted therapy has been proven to improve the overall survival of patients with SCCHN significantly, and PD-1 inhibitor combined with cetuximab has also shown promising efficacy in R/M SCCHN. This study explores the effectiveness and safety of immunotherapy combined with cetuximab and platinum neoadjuvant therapy in patients with resectable locally advanced hypopharyngeal carcinoma.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 32 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Eye & ENT Hospital of Fudan University is the lead sponsor of 121 studies on the registry; 67 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive three cycles of neoadjuvant therapy (toripalimab+cetuximab+platinum), followed by radical surgery. After surgery, participants receive radiotherapy or chemoradiotherapy according to the pathological results of the operation.
Drug: three cycles (toripalimab + cetuximab + platinum) · Procedure: Radical surgery · Radiation: Radiotherapy or chemoradiotherapy
Cetuximab 250 mg/m2 i.v. qw (first loading dose 400 mg/m2) for nine doses; Toripalimab 240 mg/m2 i.v. d1, q21d, three cycles; Cisplatin 25 mg/m2 i.v. d1-3, q21d, three cycles or Carboplatin AUC 5 i.v. d1, q21d, three cycles (patients with cisplatin contraindications or renal impairment after cisplatin use).
Also known as: Toripalimab + Cetuximab + Platinum
The attending physician should select the appropriate surgical treatment and try to perform radical laryngeal preservation surgery for patients with tumor retraction after induction therapy. Patients who cannot preserve laryngeal function due to tumor load need to undergo total laryngeal resection. According to the scope of pharyngectomy, the surgical treatments include partial laryngopharyngectomy, total laryngectomy and partial pharyngectomy, total laryngopharyngectomy, and total pharyngo-laryngo-esophagectomy. Cervical lymph node dissection was performed when necessary.
1. Using intensity-modulated radiotherapy (IMRT) technology, the dose of radiotherapy is determined according to whether there are adverse prognostic factors in the postoperative pathology, including positive margins, extracapsular invasion of lymph nodes, primary pT3 or T4, N2 lymph node lesions, peripheral nerve invasion, vascular/lymphatic infiltration. Primary site: residual GTV or tumor bed dose 60-70Gy: 1.8-2.12 Gy / fraction. Cervical lymph nodes or lymphatic drainage area: 56-70 Gy: 1.7-2.12 Gy / fraction. 2. Postoperative adjuvant concurrent chemotherapy regimen: Cisplatin 25mg/m2 i.v. d1-3, d22-24 or Carboplatin AUC 5 i.v. d1, d22 (if cisplatin contraindications).
Pathological complete response (pCR) rate after neoadjuvant chemotherapy
The pCR rate is defined as the percentage of participants who have no residual tumor cells in the resected primary tumor within 14 weeks after the start of neoadjuvant therapy.
Time frame: Within 3 weeks after surgery
Major pathologic response (MPR) rate
MPR rate, defined as no more than 10% of residual viable tumor, evaluated by experienced pathologists.
Time frame: Within 3 weeks after surgery
Objective response rate (ORR) after neoadjuvant therapy
The ORR is the proportion of patients whose tumor volume was reduced to 30% and sustained for more than 4 weeks as assessed by RECIST 1.1.
Time frame: Up to 14 weeks after the start of neoadjuvant therapy
1-year and 2-year larynx preservation rate (LPR)
LPR is the proportion of patients who avoid total laryngectomy. 1-year and 2-year LPR is defined as the probability of larynx preservation for a patient at a given time (1 year and 2 years).
Time frame: Two years post-radiotherapy
1-year and 2-year disease-free survival (DFS) rate
DFS is the time from enrollment until radiographic disease progression, local or distant recurrence, or death due to any cause. The 1-year and 2-year DFS rate is the probability of disease-free survival for a patient at a given time (1 year and 2 years).
Time frame: Two years post-radiotherapy
1-year and 2-year overall survival (OS) rate
OS is the time from enrollment to death due to any cause. The 1-year and 2-year OS rates are the probability of overall survival for a patient at a given time (1 year and 2 years).
Time frame: Two years post-radiotherapy
Adverse Effect
Adverse Effect, evaluated by CTCAE V5.0
Time frame: One year post-radiotherapy
Quality of Life Score (QoL)
Refer to EORTC QLQ-C30 (version 3, version Chinese). After the end of treatment, it is assessed every 3 months (for patients after PD, subsequent quality of life assessment is no longer performed).
Time frame: Two years post-radiotherapy
Biomarker detection
Peripheral blood samples and surgical tissue samples are retained for correlation analysis of PD-1/PD-L1 expression levels with efficacy and prognosis and screening for genes or markers related to efficacy and prognosis.
Time frame: Two years post-radiotherapy
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eye & ENT Hospital of Fudan University