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Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma

ConditionsEsophageal Squamous Cell CarcinomaNeoadjuvant ChemoimmunotherapyAdjuvant Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuo Xufeng

About this trial

The purpose of this study is to analyze esophageal cancer patients who underwent neoadjuvant immunotherapy with chemotherapy followed by esophagectomy to determine whether additional adjuvant therapy is associated with improved survival outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient volunteers to participate in the study, signs a consent form, has good compliance, and obeys the follow-up, and is willing and able to follow the protocol during the study;

Histologically-confirmed squamous cell carcinoma; tumors of the esophagus are located in the thoracic cavity;

Have not received systemic and local treatment for esophageal cancer;

Pre-treatment staging as cT1b-3N1-3M0 or T3N0M0, American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) 8th edition;

Disqualifiers

Unresectable factors, including those who are unresectable for tumor reasons or have surgical contraindications, or who refuse surgery;

Patients with supraclavicular lymph node metastasis;

Poor nutritional status, BMI<18.5Kg/m2; Patients could continue to be considered for enrollment if corrected with symptomatic nutritional support before enrollment and after assessment by the principal investigator

Allergy to any drugs;

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    Tislelizumab 200 mg q21d up to 1 year. Nad-paclitaxel 260 mg/m2, IV., every 3 weeks, 2-3 cycles. Carboplatin area under the curve = 5, IV., every 3 weeks, 2 cycles.

Treatment groups

73 Participants
are divided into 1 treatment group
Group A: Adjuvant tislelizumab plus chemothearpyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

2-year disease-free survival in non-pCR patients

The time from the first day of surgery to the first occurrence of local or distant recurrence and metastasis or death from any cause in non-pCR patients

Time frame
Disease free survival time for recurrence or death within 2 years of surgery

Secondary outcomes

1

pCR rate

Pathological complete response (pCR) rate of all patients

Time frame
4 weeks after surgery
2

major pathological response

MPR was defined as the presence of viable tumor cells≤10% in the resected tumor specimen

Time frame
4 weeks after surgery
3

2-year DFS in pCR patients

The time from the first day of surgery to the first occurrence of local or distant recurrence and metastasis or death from any cause in pCR patients

Time frame
Disease free survival time for recurrence or death within 2 years of surgery
4

R0 resection rate

No vital tumor is presented at the proximal, distal, or circumferential resection margin, then it is considered R0 resection

Time frame
4 weeks after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guo Xufeng

Lead sponsor

Shanghai Chest Hospital

Sponsor institution

Source ClinicalTrials.gov
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