Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji University

About this trial

This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Baseline stage resectable cII/III esophageal squamous cell carcinoma (8th UICC TNM stage);

Failure to receive anti-tumor treatment for esophageal squamous cell carcinoma;

Age range from 18 to 75 years old;

There are no surgical contraindications in the preoperative evaluation of various organ functions;

Disqualifiers

Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.);

Not suitable for surgery or with surgical contraindications;

Have a history of other anti PD-L1/PD-1 treatments;

Individuals with immunodeficiency or long-term systemic steroid therapy, or those who have received any immunosuppressive therapy within 7 days prior to receiving the study drug;

Trial design

Design model

Single group

Treatments tested in this trial

  • Combination of pembrolizumab and platinum containing dual drugs

    Drug

    After 2 courses of treatment with a combination of pembrolizumab and platinum containing dual drugs (albumin paclitaxel+carboplatin), surgery was performed and pembrolizumab immunomaintenance therapy continued after surgery

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Combination of pembrolizumab and platinum containing dual drugsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathological complete remission (pCR)

Defined as the absence of any residual esophageal squamous cell carcinoma cells, including the primary lesion and lymph nodes

Time frame
in two weeks after the surgical resection

Secondary outcomes

1

Major pathological remission (MPR)

The primary pathological response (MPR) is defined as residual survival tumor during surgery ≤ 10%.

Time frame
in two weeks after the surgical resection
2

R0 resection rate

Time frame
in two weeks after the surgical resection
3

Progression free survival (PFS)

Time frame
receiving therapy,up to approximately 2years.
4

Total survival time (OS)

Time frame
The time from the patient's randomization receiving therapy to death from any cause,up to approximately 2years

Other outcomes

Sponsors and contacts

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