Health TrialsbyHealthPanel

Prospective, Single-arm, Phase II Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Platinum and Immune Checkpoint Inhibitors Combined With Anlotinib for the Maintenance of Extensive Small Cell Lung Cancer After First-line Induction

ConditionSmall Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina Medical University, China

About this trial

To evaluate the efficacy and safety of liposome irinotecan combined with platinum and immune checkpoint inhibitor combined with antirotinib maintenance therapy after first-line induction

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Volunteer to join the study, sign the informed consent and sign the date, have good compliance, and cooperate with follow-up

Age≥18 years

Diagnosis of extensive stage small cell lung cancer (ES-SCLC) confirmed histologically or pathologically (according to American Veterans Lung Cancer Association, VALG staging)

ECOG 0-2

Disqualifiers

Patients with meningeal metastases or symptomatic brain metastases

Previous T cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137 agonists, or other targeting T cell drugs;

Past treatment with anlotinib

Factors affecting oral medication, such as inability to swallow, post-GI resection, chronic diarrhea, intestinal obstruction, etc

Trial design

Design model

Single group

Treatments tested in this trial

  • Liposome Irinotecan

    Drug

    Liposome irinotecan(50mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle

  • Platinum

    Drug

    Carboplatin (AUC 4-5) or Cisplatin (60mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle

  • Tislelizumab

    Drug

    Tislelizumab (200mg) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle

  • Anlotinib

    Drug

    Anlotinib (8mg) will be administered orally in a 3-week treatment cycle, once a day from day 1 to day 14 of each cycle

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: treatment groupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 6 months

Secondary outcomes

1

Objective response rate (ORR)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 6 months
2

Disease Control Rate (DCR)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 6 months
3

overall survival (OS)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 12 months
4

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

To identify the incidence of AE and SAE in clinical trial

Time frame
From the initiation of the first dose to 14 days after the last dose

Other outcomes

Sponsors and contacts

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

China Medical University, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: