Immunotherapy Plus Chemotherapy vs. Chemoradiotherapy for Thoracic Squamous Esophageal Carcinoma

Induction Therapy for Locally Advanced Tumor With Immunotherapy Plus Chemotherapy vs. Chemoradiotherapy for Thoracic Squamous Esophageal Carcinoma

The investigators conducted a phase II, prospective, two-arm clinical study to explore the efficacy of Camrelizumab combined with chemotherapy versus chemoradiotherapy for conversion therapy of potentially resectable advanced esophageal squamous cell carcinoma. This study will provide more evidence for conversion treatment of initially unresectable locally advanced esophageal squamous cell carcinoma and contribute to the development of treatment guidelines for esophageal cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Chemotherapy; Radiation Therapy
• Intervention / Treatment: Drug: Camrelizumab; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiotherapy

Detailed Description

Esophageal cancer (EC) has a higher morbidity and mortality rate than most human malignancies. The standard treatment for unresectable locally advanced esophageal squamous cell carcinoma (ESCC) is concurrent chemoradiotherapy, but survival remains limited. Carrilizumab combined with chemotherapy has been shown to have an excellent pathological remission rate in the treatment of advanced esophageal cancer and locally advanced esophageal cancer. Here, the investigators conducted a phase II, prospective, two-arm clinical study to explore the efficacy of Camrelizumab combined with chemotherapy versus chemoradiotherapy for conversion therapy in potentially resectable advanced esophageal squamous cell carcinoma. All participants meeting the inclusion criteria will be registered after signing the informed consent form. Patients with thoracic esophageal cancer with clinical staging of T4a and T4b or at least one group of lymph nodes likely to invade surrounding organs or with concomitant enlarged lymph nodes unresectable will be included in the study. According to the study plan, patients who completed two cycles of chemotherapy combined with Camrelizumab induction or concurrent chemoradiotherapy were randomly assigned to receive radical surgery after being assessed as operable. The primary endpoint was R0 removal rate in patients undergoing surgery after treatment. Secondary endpoints were major pathological response (MPR) rate, overall survival (OS), progression-free survival (PFS), and adverse events. This study will provide more evidence for the conversion treatment of initially unresectable locally advanced esophageal squamous cell carcinoma and contribute to the development of treatment guidelines for esophageal cancer.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chun Chen, Prof; Phone Number: 13365910325; Email: chenchun0209@fjmu.edu.cn

Study Locations

• China
  • Fuzhou, China, 350001
    • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• histologically-confirmed squamous cell carcinoma
• primary lesions located in the thoracic esophagus
• clinical stage cT4 or at least one group of lymph nodes invade the surrounding organs and unresectable lymph nodes
• having not received neoadjuvant therapy
• 18-75 years
• ECOG performance status of 0 or 1
• no prior chemotherapy, radiotherapy, or immunotherapy for any cancers
• adequate organ function
• expectation of R0 resection
• provision of written informed consent.

Exclusion Criteria:

• corticosteroid treatment (equivalent to prednisone >10 mg/day) within 14 days before the first day of the drug administration
• acquired immunodeficiency syndrome or active hepatitis B (DNA ≥ 104 copies/ml) or C (RNA ≥ 103 copies/ml) viral infections
• history of pneumonitis or interstitial lung disease with clinical evidence, such as interstitial pneumonia and pulmonary fibrosis features on baseline CT scans
• known or concurrent bleeding disorders or other uncontrolled diseases contraindicating surgical treatment
• physical examination or clinical trial findings that can interfere with the results or put the patient at increased risk for treatment complications
• comorbidities, including chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, and unstable mental disorders requiring therapy
• allergy to drugs used in the study
• participation in other clinical trials within 30 days before enrollment
• ineligibility for participation based on the decision of investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immumotherapy plus Chemotherapy; Paclitaxel: 175mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of 3 cycles. Cisplatin: 75mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of 3 cycles. Camrelizumab: 200mg was administered intravenously on the first day of each cycle, every 3 weeks as a cycle (Q3W), for a total of 3 cycles.	Drug: Camrelizumab; 200mgQ3w; Other Names: pdl1 Inhibitors; Drug: Paclitaxel; 175mg/m2，D1，Q3w; Other Names: Paclitaxel For Injection (Albumin Bound); Drug: Cisplatin; 75mg/m2，D1，Q3w
Experimental: chemoradiotherapy; Paclitaxel: 175mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of two cycles Cisplatin: 75mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of two cycles Radiotherapy: Irradiation mode and dose: three-dimensional conformal or intensity modulated radiotherapy technology was adopted, 41.4Gy, 1.8Gy each time, 5 times a week.	Drug: Paclitaxel; 175mg/m2，D1，Q3w; Other Names: Paclitaxel For Injection (Albumin Bound); Drug: Cisplatin; 75mg/m2，D1，Q3w; Radiation: Radiotherapy; 41.4Gy, 1.8Gy each time, 5 times a week; Other Names: Radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 removal rate	R0 removal rate in patients undergoing surgery after treatment	up to 3 months
MPR rate	major pathological response rate	up to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival	12 months
PFS	progression-free survival	12 months

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Investigators: Study Chair: Chun Chen, Prof, Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu

Study record dates

Study Major Dates

• Study Start (Anticipated): May 25, 2023
• Primary Completion (Anticipated): May 25, 2024
• Study Completion (Anticipated): May 30, 2026

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: chemoradiotherapy; conversion therapy; Immumotherapy plus Chemotherapy; advanced esophageal squamous cell carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Carcinoma; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: I-ICE Union

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Clinical trial registration, unbiased reporting of results and sharing of raw data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No