Health TrialsbyHealthPanel

Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma

ConditionsEsophageal Squamous Cell CarcinomaEsophageal CancerMetastatic Esophageal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC. It begins with a safety run-in phase, followed by a randomized controlled comparison against standard immunochemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18;

Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology;

ECOG performance status: 0-1 point;

No prior anti-tumor treatment;

Disqualifiers

Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer;

Patients who are potentially curable with surgery as assessed by investigators;

Pleural metastasis or malignant pleural effusion, pericardial effusion;

Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy;

Trial design

Design model

Sequential

Treatments tested in this trial

  • LDRT+CFRT

    Radiation

    LDRT: Primary tumor and all visible metastatic lesions, DT: 2Gy/2fx, d1-2, Q3W × 4 cycles ; CFRT: Primary tumor, DT:40-50Gy/20-25fx, starting from the 5th immunotherapy cycle

  • Immunotherapy

    Drug

    PD-1 inhibitor 200mg, Q3W, until disease progression or unacceptable toxicity or treatment reaches 2 years

  • Chemotherapy

    Drug

    Paclitaxel+ Cisplatin, Q3W × 4cycles or Paclitaxel+ Carboplatin, Q3W × 4 cycles

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Arm AExperimental treatment 3 interventions
Group B: Arm BActive comparator 2 interventions
Group C: Safety Run-in CohortExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

PFS

Progression-free survival

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
2

Safety and Feasibility of the Combined Regimen (Safety Run-in Phase)

Incidence of Treatment-Related Adverse Events (TRAEs) in the initial cohort.

Time frame
From start of treatment up to 30 days after the last dose.

Secondary outcomes

1

OS

Median overall survival

Time frame
From date of randomization until the date of death from any cause, assessed up to 36 months
2

Incidence of Grade III and higher treatment-related adverse events

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Chest Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now