Sintilimab Plus Anlotinib as Second or Further-line Therapy for ES-SCLC Who Have Progressed After Anti-PD-1/L1 Therapy

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Wannan Medical College

About this trial

The phase II study enrolled ES-SCLC patients who had disease progression after anti-PD-1/L1 therapy. Participants received intravenous sintilimab 200 mg on day one and oral daily anlotinib 8-12 mg on days 1-14 once every three weeks per cycle. The primary endpoint was objective response rate (ORR). The secondary endpoints included overall survival (OS), progression-free survival (PFS) , disease control rate (DCR) and safety.

Eligibility criteria

Qualifiers

1. At the time of signing the informed consent form, both men and women must be at least 18 years old.

2. Widespread recurrent small cell lung cancer diagnosed by histology or cytology and progressing after 3 months of standard immunization.

3. According to RECIST 1.1 criteria, patients must have at least one measurable lesion (lesions that have undergone radiotherapy must show clear progression in order to be considered measurable lesions).

4. ECOG PS score: 0-1 points.

Disqualifiers

1. Imaging shows that the tumor has invaded large blood vessels or has unclear boundaries with blood vessels.

2. Imaging shows the presence of obvious pulmonary hollow or necrotic tumors.

3. Symptomatic central nervous system metastases (such as brain metastases or meningeal metastases).

4. Patients with conditions such as malignant meningitis and spinal cord compression.

Trial design

Treatments tested in this trial

  • sintilimab combined with anlotinib

Treatment groups

25 Participants
are divided into 1 treatment group

Locations

This trial has no locations