Tislelizumab as Single-Agent Neoadjuvant Immunotherapy in Resectable Esophageal Squamous Cell Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital

About this trial

Tislelizumab in resectable esophageal squamous cell carcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years old ≤75 years old, male or female;

T2-3N0-+M0 or T1bN+M0 thoracic esophageal squamous cell carcinoma (as defined in AJCC 8th Edition) with a definite gastroscopic biopsy.

There is at least one measurable lesion (RECIST1.1 standard);

ECOG PS 0~1;

Disqualifiers

Esophageal adenocarcinoma was confirmed by histological or cytological pathology;

Previous T cell co-stimulation or immune checkpoint therapy, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other T cell-targeting drugs;

A previous or current history of cancer other than esophageal cancer, other than non-melanoma skin cancer that has been treated therapeutically, cervical cancer in situ, or other cancer that has been treated therapeutically and has not shown signs of recurrence for at least 5 years;

Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment or active pneumonia with clinical symptoms or severe lung dysfunction;

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    Tislelizumab 200mg Q3W, D1 ; 2 cycles

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: TislelizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathological complete response

Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell

Time frame
4 weeks after surgery

Secondary outcomes

1

Major pathological response

Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell

Time frame
4 weeks after surgery
2

Objective Response Rate

Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor

Time frame
At the end of Cycle 2 (each cycle is 21 days)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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