CClinicalTrials.gg
Status unknownNCT05001412Updated Aug 12, 2021

Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of ES-SCLC

A Phase 1 interventional study of Camrelizumab; apatinib; carboplatin; etoposide in Extensive Stage Small Cell Lung Cancer, sponsored by Zhou Chengzhi. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-12.

Sponsored by Zhou Chengzhi · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2021, registered Jul 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

The efficacy of PD-1/PD-L1 combined with chemotherapy in the treatment of extensive small-cell lung cancer is still unsatisfactory. PD-1/PD-L1 combined with chemotherapy and anti-angiogenic drugs may achieve better efficacy.

Read the detailed description

Camrelizumab is a humanized PD-1 monoclonal antibody. Camrelizumab combined with the antiangiogenic drug apatinib has achieved good efficacy in extensive small-cell lung cancer. Median OS is 8.4 months. In our study, subjects with extensive stage small cell lung cancers receive 2 cycles of chemotherapy followed by carrizumab combined with apatinib and chemotherapy. we hope to achieve a better outcome.

02

Conditions studied

  • Extensive Stage Small Cell Lung Cancer

Keywords

  • Camrelizumab; apatinib
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 36 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Zhou Chengzhi is the lead sponsor of 13 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Extensive stage small cell lung cancer proved by pathology.
    1. Extensive small cell lung cancer does not receive systematic treatment.
    1. limited SCLC patients have received radiotherapy and chemotherapy for more than 6 months.
    1. patients have measurable lesions according to RECIST version 1.1.
    1. Male or female who is 18 to 75 years old.
    1. ECOG PS 0 or 1.
    1. Life expectancy is more than12 weeks.
    1. Appropriate organ system function.
    1. hyroid-stimulating hormone is ULN or less (If T3 and T4 is normal, he still meets the Inclusion Criteria even the abnormal TSH. )
    1. Take proper contraceptive measures.
    1. Subjects voluntarily participate in this study and sign the informed consent.

Exclusion criteria

Exclusion Criteria:

    1. Previous treatment with apatinib, anti-programmed cell death (PD-1), anti-PD-1, or other PD-1/ PD-L1 immunotherapy.
    1. Cancer meningitis.
    1. patients had been diagnosed and/or treated for other malignancies within 5 years prior to enrollment, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
    1. There are many factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc..
    1. Uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage.
    1. Patients with spinal cord compression who were not cured or relieved by surgery and/or radiotherapy, or who were diagnosed with spinal cord compression after treatment and without clinical evidence of stable disease ≥1 week before enrollment;
    1. Patients with hypertension who cannot be well controlled by oral antihypertensive therapy, suffer from myocardial ischemia or myocardial infarction of grade I or above, arrhythmias of grade I or above , or cardiac insufficiency;
    1. Subjects had signs of bleeding, hemoptysis, or a history of unhealed wounds, ulcers, fractures within 2 months prior to initial administration.
    1. The adverse events caused by previous treatment did not completely recover.
    1. Patients with major surgery or obvious traumatic injury within 28 days before enrollment;
    1. Occurred arterial or venous thromboembolism events within 6 months.
    1. People with a history of drug abuse or mental disorders.
    1. Suffering from a serious and/or uncontrollable disease;
    1. Vaccination or attenuated vaccine received within 4 weeks.
    1. Severe allergies that require treatment with other monoclonal antibody drugs;
    1. Active autoimmune disease requiring systemic treatment within 2 years prior to the first administration;
    1. Immunosuppressive therapy with systemic or absorbable local hormones and continued for 2 weeks after the first dose;
    1. Participate in other anticancer drug clinical trials within 4 weeks;
    1. In the investigator's judgment, there are other factors that may have led to the termination of the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Cohort one

    Extensive SCLC patients who are Peripheral type or tumor vascular invasion grade one or less.

    Drug: Camrelizumab; apatinib; carboplatin; etoposide

  • Experimental
    Cohort two

    Extensive SCLC patients who are central type or tumor vascular invasion grade two to three.

    Drug: Camrelizumab; apatinib; carboplatin; etoposide

Interventions

  • DrugCamrelizumab; apatinib; carboplatin; etoposide

    2 cycle chemotherapy (carboplatin and etoposide), and then 2 cycle chemotherapy (carboplatin and etoposide) combine with Camrelizumab and apatinib, finally maintenance therapy with Camrelizumab and apatinib

06

What researchers measure

Primary outcomes

  1. Safety: Dose-limiting toxicities

    Any level 4 or greater hematologic toxicity and any level 3 or greater non-hematologic toxicity (accroding to CTC AE 5.0)

    Time frame: Followed up every 3 weeks.

Secondary outcomes

  1. PFS

    Progression Free Survival

    Time frame: Imageological diagnosis every 6 weeks

  2. 12 months OS

    12 months overall survival

    Time frame: Followed up by telephone every 2 months

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510120, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — No plan.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05001412
Lead sponsor
Zhou Chengzhi
Collaborators
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Responsible party
Zhou Chengzhi (Professor, Guangzhou Institute of Respiratory Disease) — Sponsor-investigator
First posted
Aug 12, 2021
Start date
Jan 27, 2021
Primary completion
Jan 25, 2023 (estimated)
Completion
Jan 25, 2024 (estimated)
Last update
Aug 12, 2021

Study contacts

Chengzhi Zhou, MD
Contact
doctorzcz@163.com
13560351186
Ming Liu, MD
Contact
mingliu128@hotmail.com
18688380929
Chengzhi Zhou, MD
study director · The First Affiliated Hospital of Guangzhou Medical University
Xin Chen, MD
principal investigator · Zhujiang Hospital affiliated to Southern Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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