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Status unknownNCT04128800Updated Oct 16, 2019

Appatinib Combined With S-1 in the Treatment of Small Cell Lung Cancer

A Phase 2 interventional study of Apatinib S-1 in Small Cell Lung Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-16.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To evaluate the objective remission rate and disease control rate of apatinib mesylate tablets combined with S-1 in the treatment of advanced small cell lung cancer patients with failed or dangerous radiotherapy or chemotherapy

Read the detailed description

Lung cancer is one of the malignant tumors with the highest morbidity and mortality in the world. Small cell lung cancer accounts for about 15-20% of all lung cancer. Although the initial treatment is sensitive to radiotherapy and chemotherapy, patients with small cell lung cancer are prone to recurrence and metastasis in the early stage, and ultimately lead to death due to the lack of effective treatment after the disease progresses. Patients with relapsed small cell lung cancer had a poor prognosis; untreated patients had only two to three months of expected survival.Therefore, it is urgent to find a method to treat SCLC.

Two single-arm phase II clinical studies on small cell lung cancer have evaluated the efficacy and safety of bevacizumab combined with first-line chemotherapy for extensive SCLC. Two phase II single arm studies showed good efficacy and safety. Apatinib and bevacizumab are both antiangiogenic agents. S-1 is a new oral fluoropyrimidine anticancer agent, but S-1 has shown a high remission rate for metastatic NSCLC and relapsed NSCLC.

In view of the good efficacy and tolerability of oral chemotherapeutic agent S-1, and the lack of suitable targeted drugs after NGS treatment in relapsed S LCL patients after previous multithreaded treatment, this clinical trial is to study the efficacy and safety of combination of anti-angiogenesis drugs and S-1 in patients with failed or dangerous SCLC after second-line or more radiotherapy and chemotherapy.

02

Conditions studied

  • Small Cell Lung Cancer

Keywords

  • apatinib S-1
  • Advanced lung cancer
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 20 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 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. The informed consent of the patient must be obtained before any research steps are carried out.
  2. Confirmation of SCLC: Histological diagnosis or two imaging diagnoses must be made.
  3. Late stage of SCLC, failure of second-line radiotherapy and chemotherapy or dangerous type of patients
  4. Male or female subjects > 18 years old, \< 75 years old
  5. There are objective lesions that can be measured by CT.
  6. The activity status of KPS was above 80 points.
  7. Within 14 days before admission, the bone marrow, liver and kidney functions detected by the central laboratory should meet the following laboratory data requirements:

    Hemoglobin ≥ 9.0 g/dl; absolute neutrophil count (ANC)1,500 /mm3 ; platelet count ≥ 50,000 /ul; total bilirubin \< 2 mg/dL (3 mg/dL, Child B); ALT and AST \< 5-fold normal value upper limit; alkaline phosphatase \< 4-fold normal value upper limit; PT > 50% or PT-INR \< 2.3, or greater than the control value \< 6 seconds.

  8. For subjects taking warfarin, the subjects were closely monitored at least once a week until the INR measurement of the subjects was stable at the time of each administration according to the local treatment standards.
  9. The upper limit of normal serum creatinine \< 1.5 times is
  10. For pregnant women, the results of serum pregnancy test must be negative within 14 days before the start of treatment.
  11. All male and female patients participating in this study must adopt reliable contraceptive measures during the trial and within two week.

Exclusion criteria

Exclusion Criteria:

  1. KPS \< 60 points, or expected survival \< 3 months.
  2. Severe cardiovascular diseases .
  3. Uncontrollable hypertension .
  4. History of human immunodeficiency virus (HIV) infection .
  5. Active clinical severe infections (Grade 2, NCI-CTCAE Version 3.0) .
  6. Epilepsy patients requiring medication (e.g. steroids or antiepileptic drugs) .
  7. History of allogeneic organ transplantation .
  8. Patients with signs of hemorrhage or history of disease.
  9. Patients undergoing renal dialysis.
  10. Chronic obstructive pulmonary emphysema .
  11. Gastrointestinal bleeding within 30 days before admission .
  12. Patients have a history of esophageal varices bleeding, and subsequently did not receive effective treatment or treatment to prevent recurrence of bleeding.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Apatinib and S-1 group

    Drug: Apatinib S-1

Interventions

  • DrugApatinib S-1

    apatinib 250 mg PO qd; S-1 40 mg PO in the morning and 60 mg PO in the evening; 14 days in combination, 21 days in a cycle.

    Also known as: apatinib mesylate tablets

06

What researchers measure

Primary outcomes

  1. Objective Response Rate(ORR)

    Time frame: one year

Secondary outcomes

  1. Disease Control Rate (DCR)

    Time frame: one year

Other outcomes

  1. Progression free survival (PFS)

    Time frame: one year

  2. Overall survival (OS)

    Time frame: one year

  3. Quality of life (QoL)

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Tianjin Medical University Cancer Institute and Hospital
    Tianjin, Tianjin 300060, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

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 Oct 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04128800
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Responsible party
Sponsor
First posted
Oct 16, 2019
Start date
Oct 2019 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Dec 2021 (estimated)
Last update
Oct 16, 2019

Study contacts

Ning bo Liu, MD
Contact
liuningbo@tjmuch.com
15822117210
Ping Wang, MD
Contact
wangping99999@yahoo.com
18622221112
Ning bo Liu, MD
principal investigator · Tianjin Medical University Cancer Institute and Hospital

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 Oct 2019. You cannot join it, but the record below documents what was studied.

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