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Tislelizumab Combined With Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma Followed by CRT or Surgery

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

About this trial

To explore the non-inferiority of the 2y-OS rate of tislelizumab combined with chemotherapy after sequential CRT in the treatment of resectable esophageal squamous cell carcinoma compared with the surgical group

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subjects were included in this study and signed the informed consent form.

Male or female patients aged between 18 and 75 years old;

Patients diagnosed with esophageal squamous cell carcinoma by histopathology;

According to the 8th edition of the AJCC Esophageal cancer TNM staging system, it is located in cT2N+ or cT3-4aNanyM0 (confirmed by enhanced CT/MRI of the chest and abdomen), and the lesion is located in the thoracic segment.

Disqualifiers

There are clinically uncontrolled pleural effusions, pericardial effusions or ascites that require repeated drainage or medical intervention (within 2 weeks before randomization);

It is known that there is intolerance or resistance to the chemotherapy specified in the trial protocol;

Have received any other ESCC anti-tumor treatments (e.g., targeted treatments for PD-1, PD-L1, PD-L2, or other tumor immunotherapy, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor treatments);

Patients with active autoimmune diseases or a history of autoimmune diseases that may recur, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tislelizumab

    Drug

    200mg，d1，q3w，1years

  • Albumin-Bound Paclitaxel

    Drug

    125mg/m2，d1，d8，q3w，2cycles

  • cis-platinum

    Drug

    75mg/m2，d1，q3w，2cycles

  • Surgery

    Procedure/Surgery

    Radical resection of esophageal cancer

  • Radiation

    Radiation

    50.5Gy/28f

  • Nedaplatin

    Drug

    80-100mg/m2，d1，q3w，2cycles

  • Carboplatin

    Drug

    AUC=5，d1，q3w，2cycles

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: CRT+TislelizumabExperimental treatment 6 interventions
Group B: surgery+TislelizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival rate of 2 years

The proportion of patients who were still alive from the start of randomization (or the start of treatment in a single-arm trial) to 2 years

Time frame
2 years

Secondary outcomes

1

objective response rate

According to the recognized response evaluation criteria (such as recist Version 1.1 for Solid tumors), the proportion of patients whose tumor volume reduction reaches the pre-specified value and can maintain the minimum time limit requirements

Time frame
every 2 weeks until 3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: