Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer

December 15, 2023 updated by: Wen Yu, Shanghai Chest Hospital

A Phase I/II Multicenter Study Evaluating the Efficacy and Safety of Induction Immunochemotherapy Followed by Concurrent Immuno-Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Cancer(SCR-ESCC-02)

SCR-ESCC-02 is a multicenter, phase I/II clinical study to investigate the safety and efficacy of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 therapy in patients diagnosed with locally advanced, unresectable esophageal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Immunotherapy has shown promising results in advanced esophageal cancer, but its optimal integration into the management of unresectable locally advanced disease remains uncertain. The significant tumor regression and reduced tumor residual achieved through immunochemotherapy offer an opportunity to enhance the effectiveness of subsequent radiotherapy. This phase I/II clinical study aims to investigate the efficacy and safety of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 for patients with unresectable locally advanced esophageal cancer. The study's co-primary endpoints are progression-free survival (PFS) and treatment completion rate.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 and 75 years.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  3. Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification.
  4. Ineligibility for surgical resections due to patients' unwillingness for surgery, technically unresectable disease, or being medically unfit for surgery.
  5. No prior anti-tumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
  6. Adequate hematological, pulmonary, cardiac, hepatic, renal, and thyroid function.
  7. Willingness to use contraception with an adequate method throughout the study.
  8. Documented informed consent.

Exclusion Criteria:

  1. History of malignant disease within the 5 years preceding enrollment or presence of other malignant tumors or non-squamous cell carcinoma components.
  2. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation as determined by the investigators.
  3. Weight loss exceeding 20% within the 90 days prior to the first day of drug administration.
  4. Presence of long-standing unhealed wounds or fractures or undergoing major surgical resections within 60 days preceding the first day of drug administration.

  5. Presence of any severe or uncontrolled coexisting diseases, including but not limited to:

    • Uncontrolled hypertension
    • History of interstitial lung disease or non-infectious pneumonia
    • Active hepatitis B or C, syphilis, or other active and uncontrolled infections
    • Cardiac insufficiency (NYHA≥2)
    • Renal dysfunction requiring dialysis
    • Active autoimmune disease
    • History of acquired or congenital immunodeficiency diseases
  6. Occurrence of serious arterial/venous thrombotic events within 6 months prior to the first day of drug administration.
  7. History of psychotropic substance abuse or inability to quit, or patients with psychotic disorders.
  8. Allergy to study drugs.
  9. Patients deemed unsuitable for participation due to severe comorbidities or other reasons determined by the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IC+ICRT group
2 cycles of PD-1 inhibitor + nab-paclitaxel + cisplatin followed by concurrent PD-1 inhibitor + radiotherapy (45-50Gy/25fx) + nab-paclitaxel + cisplatin
Drug: PD-1inhibitor
PD-1 inhibitor, Q3W, until disease progression or unacceptable toxicity or treatment reaches 1 year
Other Names:
  • Immunotherapy
Drug: nab-paclitaxel + cisplatin
Induction phase: nab-paclitaxel + cisplatin, Q3W × 2 cycles; Concurrent ICRT phase: nab-paclitaxel + cisplatin, QW × 5 cycles
Other Names:
  • Chemotherapy
Radiation: Radiotherapy
Primary tumor and metastatic lymph nodes, DT:45-50Gy/25fx, starting within 4 weeks following the completion of the last induction immunochemotherapy cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Assessed up to 60 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Assessed up to 60 months
Treatment completion rate
Time Frame: 1 year
The Treatment Completion Rate is defined as the percentage of patients who successfully completed concurrent immuno-chemoradiotherapy.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 1 year
Objective response rate (ORR), defined as the proportion of patients with a complete response or partial response after Immuno-Chemoradiotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST)
1 year
Overall survival
Time Frame: Assessed up to 60 months
From date of randomization until the date of death from any cause
Assessed up to 60 months
Incidence of Adverse events (AE) or severe adverse events (SAE)
Time Frame: 1 year
Adverse events (AE) or severe adverse events (SAE) occurring within 3 months post-radiotherapy, and the incidence of treatment discontinuation due to AE/SAE
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Investigators

  • Principal Investigator: Wen Yu, M.D, Shanghai Chest Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Estimated)

December 18, 2023

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCR-ESCC-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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