Neoadjuvant Treatment of Locally Advanced Hypopharyngeal Cancer With Adebrelimab Combined With TP Chemotherapy Regimen

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of Xiamen University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Adebrelimab+Albumin paclitaxel +Cisplatin

    Drug

    1. Adebrelimab:1200mg, ivgtt, D1, Q3W; 2. Albumin paclitaxel :260mg/m2, ivgtt, D1, Q3W; 3. Cisplatin :60mg/m2, ivgtt, D1, Q3W.

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathological complete response (pCR)

Pathological examination of the resected tissue samples did not reveal any residual tumor cells.

Time frame
Six months

Secondary outcomes

1

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.

Time frame
six months
2

Surgical R0 resection rate

The proportion of the resection margin without residual cancer cells

Time frame
Six months
3

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.

Time frame
six months
4

The intensity of the surgery has decreased

The researchers determined whether the surgical intensity had decreased based on the subjects' conditions.

Time frame
six months

Other outcomes

Sponsors and contacts

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