Immunotherapy Plus Chemotherapy vs. Chemoradiotherapy for Thoracic Squamous Esophageal Carcinoma

NCT05821452 | Not Yet Recruiting Phase 2

• 1 other identifier: I-ICE Union
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy; Radiation Therapy

Keywords

Immumotherapy plus Chemotherapy; conversion therapy; advanced esophageal squamous cell carcinoma; chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• OS

  12 months

• PFS

  12 months

Study Arms (2)

Immumotherapy plus Chemotherapy

EXPERIMENTAL

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; Drug: Paclitaxel; Drug: Cisplatin

chemoradiotherapy

EXPERIMENTAL

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; Drug: Cisplatin; Radiation: Radiotherapy

Interventions

Camrelizumab DRUG

200mgQ3w

Also known as: pdl1 Inhibitors

Immumotherapy plus Chemotherapy

Paclitaxel DRUG

175mg/m2，D1，Q3w

Also known as: Paclitaxel For Injection (Albumin Bound)

Immumotherapy plus Chemotherapy; chemoradiotherapy

Cisplatin DRUG

75mg/m2，D1，Q3w

Immumotherapy plus Chemotherapy; chemoradiotherapy

Radiotherapy RADIATION

41.4Gy, 1.8Gy each time, 5 times a week

Also known as: Radiation therapy

chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, 350001, China

Location

Related Publications (1)

• Chen M, Huang Y, Zhang S, Zheng Y, Zeng T, Chen C, Zheng B. Camrelizumab in combination with chemotherapy versus concurrent chemoradiotherapy for the conversion of locally advanced unresectable oesophageal squamous carcinoma: protocol for a two-arm, open-label phase II trial. BMJ Open. 2024 Feb 28;14(2):e075421. doi: 10.1136/bmjopen-2023-075421.

  PMID: 38418234 DERIVED

MeSH Terms

Interventions

camrelizumab; Paclitaxel; Injections; Cisplatin; Radiotherapy

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Chun Chen, Prof

  Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu

  STUDY CHAIR

Central Study Contacts

Chun Chen, Prof

CONTACT

13365910325; chenchun0209@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: April 20, 2023
• Study Start: May 25, 2023
• Primary Completion: May 25, 2024
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)