Comparing ICI Followed By CCRT And CCRT Followed By Immunotherapy In Unresectable LA-ESCC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

A total of 120 patients with unresectable, locally advanced esophageal squamous cell carcinoma patients will be enrolled in this study and randomly divided into two groups.

Arm A: After 2 cycles of induction adebrelimab plus chemotherapy, patients will be treated with concurrent chemoradiotherapy (50.4Gy/1.8Gy/28f), and adebrelimab will maintain to PD or for a maximum of 15 cycles.

Arm B: Patients will be treated with concurrent chemoradiotherapy (50.4Gy/1.8Gy/28f) and adebrelimab will maintain to PD or for a maximum of 17 cycles.

This study will compare the efficacy of immunotherapy in the induction and maintenance phases of radiotherapy, optimize more precise treatment plans, and potentially further increase the survival of ESCC patients.

Eligibility criteria

Qualifiers

Volunteered to participate, cooperated with follow-up visits, documented informed consent;

Aged 18 -75 years, both male and female;

Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1( supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC); clinically staged as II-IVb inoperable locally advanced ESCC (including non-resectable, or with contraindications to or refusal of surgery);

Measurable and/or unmeasurable lesions as defined by the criteria for evaluating the efficacy of solid tumors (RECIST1.1) and the Japanese Classification of Esophageal Cancer (12th Edition: Part II);

Disqualifiers

Surgery for esophageal cancer;

Esophageal fistulae due to infiltration of the primary tumour;

Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation

Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;

Trial design

Treatments tested in this trial

  • Adebrelimab
  • Nab paclitaxel
  • Carboplatin
  • radiation

Treatment groups

120 Participants
are divided into 2 treatment groups