About this trial
To evaluate the efficacy and safety of adebrelimab combined with TP chemotherapy regimen as neoadjuvant therapy for locally advanced hypopharyngeal cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age: 18 to 70 years old, gender not limited;
2.ECOG PS score: 0-1 point;
3. Patients who are capable of surgical resection and willing to undergo it;
4. Hypopharyngeal cancer diagnosed by histology/cytology and imaging, with a clinical stage of T1-2, N1-3 or T3-4, any N;
Disqualifiers
1. Have received any anti-tumor treatment in the past, including radiotherapy, chemotherapy, targeted therapy, immunotherapy and traditional Chinese medicine anti-tumor treatment (except for the treatment of malignant tumors that have been completely cured in the past and have no recurrence or metastasis for ≥5 years);
2. Have undergone surgical operations targeting the primary tumor or lymph nodes in the past;
3. Patients who have suffered from any malignant tumors in the past five years (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
4. Patients with distant metastases;
Trial design
Single group
Treatments tested in this trial
Adebrelimab+Albumin paclitaxel +Cisplatin
Drug1. Adebrelimab:1200mg, ivgtt, D1, Q3W; 2. Albumin paclitaxel :260mg/m2, ivgtt, D1, Q3W; 3. Cisplatin :60mg/m2, ivgtt, D1, Q3W.
Treatment groups
Trial outcomes
Primary outcomes
Pathological complete response (pCR)
Pathological examination of the resected tissue samples did not reveal any residual tumor cells.
Secondary outcomes
Major pathological response (MPR)
Major pathological response (MPR) is defined as the presence of active tumor tissue in surgical specimens ≤10% at the time of tumor resection.
Surgical R0 resection rate
The proportion of the resection margin without residual cancer cells
Laryngeal function retention rate
It refers to the proportion of subjects whose laryngeal functions (including vocalization, breathing and swallowing functions) are successfully preserved during the treatment process through methods such as surgery, radiotherapy, chemotherapy or comprehensive treatment.
The intensity of the surgery has decreased
The researchers determined whether the surgical intensity had decreased based on the subjects' conditions.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: