Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
ID06430658

Neoadjuvant Total Treatment for Borderline Unresectable Esophageal Squamous Cell Carcinoma A Prospective Randomized Three-Arm Trial Evaluating Tislelizumab with Chemoradiotherapy

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-12-27

90

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating treatment options for patients with locally advanced esophageal squamous cell carcinoma (ESCC) that cannot be surgically removed. This phase II trial evaluates three different conversion therapy approaches, including combining immunotherapy with chemoradiotherapy, to improve outcomes such as complete tumor removal (R0 resection), treatment safety, and survival rates. The study focuses on patients with borderline unresectable ESCC, aiming to provide new insights into effective treatment strategies for this challenging condition. Participants receive Tislelizumab, a specially designed immune therapy antibody, combined with chemoradiotherapy in various sequences to convert tumors to a resectable state. The treatments are administered according to assigned groups in a three-arm randomized design. The study carefully monitors treatment responses and side effects to assess the therapies' ability to enable surgery and improve patient outcomes. Throughout the study, patients undergo thorough assessments including physical exams, lab tests, and imaging to evaluate tumor status and organ function. Researchers track the primary outcome of R0 resection rate at 4 months, along with adverse events, morbidity, mortality, and survival at one year. The study also monitors patients' overall health and treatment tolerance to ensure safety and gather comprehensive data on the therapy's effectiveness over time.

CONDITIONS

Official Title

Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with esophageal squamous cell carcinoma confirmed by tissue examination
  • Cancer located in the thoracic esophagus
  • No previous cancer treatments like surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
  • Locally advanced ESCC considered borderline unresectable or with extracapsular lymph node involvement
  • Karnofsky Performance Scale score of 70 or higher
  • Normal organ function including acceptable blood counts and liver and kidney function tests
Not Eligible

You will not qualify if you...

  • Having other primary cancers except cured basal cell skin cancer or cervical carcinoma in situ
  • Any prior anti-cancer treatment before this study
  • Advanced cancer with distant metastases including supraclavicular lymph nodes
  • Major blood vessel involvement with high risk of bleeding
  • High risk of esophageal perforation during treatment
  • Active infections such as tuberculosis or hepatitis B or C
  • Allergy to cancer treatment drugs including PD-1 inhibitors or chemotherapy
  • Heart or lung problems preventing tolerance of treatment or surgery
  • Pregnant or breastfeeding women or women without effective contraception
  • Not meeting inclusion criteria as judged by investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, China, 100021

Actively Recruiting

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Research Team

X

Xin Wang, Doctor

Z

Ziyu Zheng, B.M

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Frequently Asked Questions

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Neoadjuvant Total Treatment for Borderline Unresectable Esophageal Squamous Cell Carcinoma A Prospective Randomized Three-Arm Trial Evaluating Tislelizumab with Chemoradiotherapy | DecenTrialz