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

ConditionsEsophageal Squamous Cell CarcinomaOligometastatic DiseaseRadiotherapy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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%

Trial design

Design model

Parallel

Treatments tested in this trial

  • PD-1 inhibitor+/- chemotherapy combined with local therapy

    Combination product

    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

  • systemic therapy alone

    Drug

    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)

Treatment groups

354 Participants
are divided into 2 treatment groups
Group A: PD-1 inhibitor+/- chemotherapy combined with local therapyExperimental treatment 1 intervention
Group B: PD-1 inhibitor +/- chemotherapy aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone

The time between the start of the study treatment(day 1) and progression disease(PD)

Time frame
3-year

Secondary outcomes

1

overall survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone

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

Time frame
3-year
2

treatment related side effect

Record the treatment related side effects including acute and late side effects

Time frame
acute side effects within 3 months, late side effects for 3 months later
3

local control rate

the portion of patients who do not develop progression disease or exacerbation of clinical symptoms despite stable disease

Time frame
1-year, 3-year

Other outcomes

Sponsors and contacts

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Fudan University

Lead sponsor

Source ClinicalTrials.gov
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