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

NCT06190782 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2024-05-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

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)

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Kuaile Zhao, MD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-27
Primary Completion
2025-09-27
Completion
2027-09-27

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06190782 on ClinicalTrials.gov