Adebrelimab Combined With Albumin Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable ESCC

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHarbin Medical University

About this trial

This is a multi-center, single-arm, phase II clinical study designed to observe and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 to 75 years old, no limit to male or female;

Surgically resectable locally advanced esophageal squamous cell carcinoma confirmed by histology or cytology (clinical stage: stage IIa-IIIb);

Have measurable lesions and meet RECIST v1.1) standards;

Have not received any anti-tumor systemic treatment for esophageal cancer in the past;

Disqualifiers

Patients with locked lymph node metastasis;

Have a history of other malignant tumors in the past 5 years, except for cervical carcinoma in situ or cutaneous squamous cell carcinoma that has been fully treated, or basal cell carcinoma of the skin that has been basically controlled;

Suffering from bleeding disorders or a history of bleeding disorders;

Have undergone major surgery or serious trauma within 4 weeks before taking the study drug for the first time;

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    adebrelimab, IV

  • albumin paclitaxel

    Drug

    albumin paclitaxel, iv

  • Nedaplatin

    Drug

    Nedaplatin,IV

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: Immuno-chemotherapy for locally advanced ESCCExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

pathological complete remission rate

After neoadjuvant therapy and surgery, there were no residual surviving tumor cells in the tumor bed in the postoperative specimens (% RVT=0)

Time frame
up to 24 months

Secondary outcomes

1

R0 resection rate

The tumor lesion was completely removed, and no residual cancer cells were found on the cutting edge under the microscope

Time frame
up to 24 months
2

Main pathological remission

After neoadjuvant therapy and surgery, the proportion of tumor cells remaining alive in the tumor bed in the postoperative specimen is less than or equal to 10% (% RVT ≤ 10)

Time frame
up to 24 months
3

objective response rate

The proportion of patients whose tumors have shrunk to a certain amount and remained in remission for a certain period of time, including complete response (CR) and partial response (PR).

Time frame
up to 24 months
4

Disease-free survival

It was calculated from the time of first administration of study drug until disease progression or death.

Time frame
up to 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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