Exploratory Clinical Study of Camrelizumab Combined With Concurrent Chemoradiotherapy as an Organ-preserving Strategy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Summary

This study is a prospective, exploratory clinical study aimed at evaluating the feasibility and safety of camrelizumab combined with synchronous chemoradiotherapy as an organ-preserving strategy for locally advanced resectable esophageal squamous cell carcinoma.

The study targets patients with locally advanced resectable stage II/III/IVa (cT1b-4aN0-3M0) ESCC. A total of 164 subjects are expected to be enrolled.

The study is a randomized, non-controlled, open-label trial. Subjects meeting the inclusion criteria will be randomly assigned in a 1:1 ratio to receive either camrelizumab combined with radiotherapy, albumin-bound paclitaxel, and carboplatin treatment (Cohort 1) or camrelizumab combined with radiotherapy and capecitabine treatment (Cohort 2).

The screening period for the study is 28 days. After completing screening examinations and assessments, eligible subjects will be randomly assigned to the following treatment regimens.

Cohort 1:

* Camrelizumab: 200 mg on Day 1, every 3 weeks
* Radiotherapy: 50-50.4 Gy / 25-28 fractions, Days 1-5, once a week
* Albumin-bound paclitaxel: IV infusion, 60-80 mg/m², Day 1, weekly
* Carboplatin: IV infusion, AUC=1-1.5, Day 1, weekly

Each cycle lasts 3 weeks, with 2-4 cycles of medication.

Efficacy evaluation (imaging and endoscopic examination) will be conducted within 6 weeks after the completion of treatment. If the efficacy evaluation indicates cCR, subjects will enter Group A1 and receive camrelizumab maintenance therapy (maximum 1 year). If the efficacy evaluation does not reach cCR, after consultation between the investigator and the subject, they will enter Group B1 to undergo radical surgery, followed by camrelizumab monotherapy maintenance treatment (maximum 1 year).

Cohort 2:

Camrelizumab: ivgtt, 200 mg, D1, Q3W Radiotherapy: 50-50.4 Gy / 25-28 fractions, D1-D5, QW Capecitabine: p.o. 625 mg/m², BID, D1-D14, Q3W; One cycle lasts 3 weeks, with 2-4 cycles of medication. Efficacy evaluation (imaging and endoscopy) will be conducted within 6 weeks after treatment completion. If the efficacy is assessed as cCR, the patient will enter Group A2: receive camrelizumab maintenance therapy (up to 1 year); if efficacy is not cCR, the patient will enter Group B2: undergo radical surgery, followed by camrelizumab monotherapy maintenance (up to 1 year).

This study will follow up subjects for disease recurrence and disease-free survival for at least 2 years. After all subjects complete the treatment/termination visit, efficacy will be evaluated.

Conditions

• Late-stage Resectable Esophageal Squamous Carcinoma

Interventions

DRUG

Camrelizumab (anti-PD-1 inhibitor)

200 mg, Day 1, every 3 weeks ,One cycle lasts 3 weeks, with 2-4 cycles of medication.

DRUG

Albumin-Bound Paclitaxel /nab-Paclitaxel

IV infusion, 60-80 mg/m², Day 1, weekly;One cycle lasts 3 weeks, with 2-4 cycles of medication.

DRUG

Carboplatin

IV infusion, AUC=1-1.5, Day 1, weekly ;One cycle lasts 3 weeks, with 2-4 cycles of medication.

DRUG

Capecitabine

p.o. 625 mg/m², BID, D1-D14, Q3W; One cycle is 3 weeks, with 2-4 cycles of medication.

RADIATION

radiotherapy

50-50.4 Gy / 25-28 fractions, D1-D5, QW ,One cycle is 3 weeks, with 2-4 cycles of medication.

Sponsors & Collaborators

• The First Affiliated Hospital of Henan University of Science and Technology

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-21

Primary Completion

2028-12-31

Completion

2030-12-31

Countries

• China

Study Locations