Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor

April 30, 2024 updated by: Kuai Le Zhao, MD, Fudan University

Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma

Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone.

The primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with oligometastatic squamous cell carcinoma were enrolled and 2:1 randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy (radiotherapy, surgery, radiofrequency/microwave ablation, etc.) or PD-1 inhibitor +/- chemotherapy alone. Different local therapy techniques are allowed to be used on different lesions in the same patient.All suspected malignant lesion should be included in local treatment planning in principle.

The primary end point was progression-free survival (PFS). The second end points included overall survival, side effects and local control.

Study Type

Interventional

Enrollment (Estimated)

354

Phase

  • Phase 3

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 Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • 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. ≥18 years old; 2. ECOG 0-1; 3. Esophageal squamous cell carcinoma 4. ASTRO/ESTRO defined genuine oligometastatic disease and consistent with: i. ≤4 distant metastases, ii. ≤3 metastatic lesions within a single organ, iii. maximum diameter of each metastatic lesion ≤5cm; 5. ≥1 pathologically diagnosed metastases

Exclusion Criteria:

  • 1. History of disseminated metastases or ASTRO/ESTRO defined induced oligometastatic disease 2.Esophageal perforation/hemorrhage 3.Progression disease after PD-1 inhibitor treatment 4.In-field recurrence 5.Intolerance to chemotherapy or immunotherapy 6.lung V20>25%

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD-1 inhibitor+/- chemotherapy combined with local therapy
Patients randomized to this arm will receive local treatment combined with systemic treatment (immunotherapy or chemo-immunotherapy)
Combination product: PD-1 inhibitor+/- chemotherapy combined with local therapy

  1. PD-1 inhibitor +/- Chemotherapy PD-1 inhibitor: all FDA approved PD-1 inhibitor producter is suitable

    First line:

    i. TP: paclitaxel 135-175mg/m2,d1+ DDP25mg/m2, d1-3 or 75mg/m2,d1;q21d (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternative) or ii. PF: DDP Second line (other platinum-based agents permitted as alternative such as carboplatin, nedaplatin, oxaliplatin, lobaplatin, etc.) i. Docetaxel or ii. Irinotecan or iii. Paclitaxel (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternatives)

  2. Local therapy i. Radiotherapy GTV=all suspected lesions. SBRT: for lung, liver, adrenal gland, celiac lymphnode metatstases 48Gy/6fx; for spine metastatic disease 30Gy/10Fx; for brain metastases 24Gy/30fx; IMRT: for bone metastatic disease 30Gy/10fx; for esophageal lesion or lesion unsuitable of SBRT 50.4Gy/28fx; ii. Surgery iii. Radiofrequency/microwave ablation
Active Comparator: PD-1 inhibitor +/- chemotherapy alone
Patients randomized to this arm will receive only systemic treatment (immunotherapy or chemo-immunotherapy)
Drug: systemic therapy alone

1.PD-1 inhibitor +/- Chemotherapy PD-1 inhibitor: all FDA approved PD-1 inhibitor producter is suitable

First line:

i. TP: paclitaxel 135-175mg/m2,d1+ DDP25mg/m2, d1-3 or 75mg/m2,d1;q21d (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternative) or ii. PF: DDP Second line (other platinum-based agents permitted as alternative such as carboplatin, nedaplatin, oxaliplatin, lobaplatin, etc.) i. Docetaxel or ii. Irinotecan or iii. Paclitaxel (albumin-bound paclitaxel or paclitaxel liposomes as alternative of paclitaxel permitted as alternatives)

Other Names:
  • the systemic therapy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone
Time Frame: 3-year
The time between the start of the study treatment(day 1) and progression disease(PD)
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone
Time Frame: 3-year
The time between the start of the study treatment(day 1) and death from an cause or last follow-up for patients alive at the end of the study
3-year
treatment related side effect
Time Frame: acute side effects within 3 months, late side effects for 3 months later
Record the treatment related side effects including acute and late side effects
acute side effects within 3 months, late side effects for 3 months later
local control rate
Time Frame: 1-year, 3-year
the portion of patients who do not develop progression disease or exacerbation of clinical symptoms despite stable disease
1-year, 3-year

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Study Director: Kuaile Zhao, MD, Fudan University

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)

September 27, 2022

Primary Completion (Estimated)

September 27, 2025

Study Completion (Estimated)

September 27, 2027

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Estimated)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESO-Shanghai20

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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