Adebrelimab Combined With Neoadjuvant Chemotherapy in Borderline Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This clinical trial aims to preliminarily evaluate the efficacy and safety of adebrelimab combined with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy for borderline resectable locally advanced esophageal squamous cell carcinoma (ESCC). The primary research objectives are to increase the R0 resection rate in such patients, thereby reducing the recurrence rate and improving overall survival (OS), as well as avoiding adverse reactions associated with radiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients with cervical esophageal squamous cell carcinoma.

Patients with distant metastasis.

Patients with nearly complete esophageal obstruction confirmed by endoscopy who require interventional therapy for decompression.

Patients with prior placement of esophageal or tracheal stents.

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab Injection

    Drug

    Study participants shall complete the informed consent process and undergo multidisciplinary team (MDT) review for esophageal cancer. Patients confirmed as having borderline resectable disease and meeting all inclusion/exclusion criteria will be enrolled and receive treatment with adebrelimab plus albumin-bound paclitaxel and carboplatin.The treatment regimen is administered in 3-week cycles. Efficacy evaluation will be performed after 2 cycles.

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

R0 resection rate

The proportion of patients with tumor margins showing no residual cancer cells under the microscope after surgical resection. That is, the proportion of patients in PPS achieving R0 resection.

Time frame
From patient enrollment to two weeks post-surgery

Secondary outcomes

1

Overall survival

OS is the time interval from the start of treatment to death due to any reason or loss of follow-up

Time frame
up to 5 years post-surgery
2

Progression free survival

Disease free survival (DFS) refers to the time from the start of treatment until disease recurrence or death from any cause, whichever occurs first.

Time frame
up to 5 years post-surgery
3

Pathologic complete response rate

Time frame
From patient enrollment to two weeks post-surgery
4

Incidence of perioperative complications

Time frame
from the first drug administration to within 30 days after the last intended treatment

Other outcomes

Sponsors and contacts

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