A Study of Simmitinib Versus Chemotherapy for Participants With Advanced Oesophageal Squamous Cell Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Runshi Pharmaceutical Technology Co., Ltd

About this trial

To evaluate the overall survival of simmitinib versus investigator's choice of chemotherapy for Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Absolute Neutrophil count (ANC) ≥ 1.5 × 10^9/L;

Platelet count (PLT) ≥ 100× 10^9/L;

Hemoglobin (Hb) ≥ 90 g/L;

Serum creatinine ≤ 1.5 × ULN and Creatinine clearance (CCr)≥60mL/min(According to the Cockcroft-Gault formula);

Disqualifiers

1. Patients who have previously received any anti-tumor therapy within 4 weeks prior to randomization; 2. Patients who have previously received major surgical treatment、open biopsy、other clinical trial drug treatment or any live attenuated vaccine within 4 weeks prior to randomization, or are expected to received any live attenuated vaccine during the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • simmitinib

    Drug

    simmitinib 6mg,QD ,3 weeks on 1 week off

  • investigator's choice of chemotherapy,include docetaxel or irinotecan.

    Drug

    docetaxel injection 75mg/m\^2,d1,every 3 weeks or ilinotecan injection 180mg/m\^2,d1,every 2 weeks

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: simmitinibExperimental treatment 1 intervention
Group B: investigator's choice of chemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

OS

Time frame
up to approximately 3 years

Secondary outcomes

1

ORR

Objective Response Rate (ORR) evaluated by investigators based on RECIST 1.1

Time frame
up to approximately 3 years
2

PFS

Progression-free Survival

Time frame
up to approximately 3 years
3

DCR

Disease Control Rate

Time frame
up to approximately 3 years
4

DOR

Duration of Objective Response

Time frame
up to approximately 3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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