Trilaciclib Prevents Myelosuppression With Chemoradiotherapy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

To evaluate the protective effect of Trilaciclib on myelosuppression in patients with limited-stage small cell lung cancer associated with concurrent chemoradiotherapy and discuss the effect of gut microbiota changes on myelosuppression

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The histopathology is limited-stage small cell lung cancer.

ECOG score 0-2.

Good organ function (no blood transfusions, no hematopoietic stimulating factors, no transfusions of albumin or blood products within 14 days prior to the examination).

It is suitable for patients treated with Trilaciclib combined with etoposide plus cisplatin or carboplatin.

Disqualifiers

Brain metastases with clinical symptoms require local radiotherapy or hormone therapy.

Active infections require systemic treatment.

Subjects with active, known or suspected autoimmune disease or history of autoimmune disease.

Combined with other tumors.

Trial design

Design model

Single group

Treatments tested in this trial

  • Trilaciclib

    Drug

    During concurrent chemoradiotherapy in limited-stage small cell lung cancer, Trilaciclib is administered prophylactically before the first cycle of chemotherapy

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Trilaciclib combined with concurrent chemoradiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of severe neutropenia

Grade 3/4 decline in neutropenia after the first cycle of chemotherapy during radiotherapy

Time frame
14 days
2

Duration of severe neutropenia

Duration of severe neutropenia after the first cycle of chemotherapy during radiotherapy (ANC\<1.0×10\^9/L for more than 5 days)

Time frame
5 days
3

Occurrence of hematological toxicity

Grade 3/4 decline in neutrophils, platelets, and red blood cells

Time frame
5 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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