CClinicalTrials.gg
Status unknownNCT04161352R-helperUpdated Nov 13, 2019

Endostar Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III NSCLC

An observational study in Unresectable Stage III NSCLC, sponsored by Zhejiang Cancer Hospital. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-11-13.

Sponsored by Zhejiang Cancer Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 75 Years
Sex
All
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Study summary

The chemoradiotherapy (CCRT) is still a standard treatment for the unresectabl stage III NSCLC.However, prognosis following this treatment is generally poor, with 5-year survival of 15-20%. The result of published HELPER study had showed that Endostar, a kind of angiogenesis agent, in combination with CCRT could improve the efficacy and safety. In order to verify the rusults, the investigators design the current study.

Read the detailed description

The current study is a observation study in the real world setting. The 500 patients in compliance with Enrollment Criteria will be as the objects of observation. The procedure of study include the period of screening, treating and follow-up. The duration of study is about two and half year. The data entrying will be done by CRC, using the EDC system. CRA will audit the quality of data regularly.

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Conditions studied

  • Unresectable Stage III NSCLC
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In context

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

the patients with untreated pathologically confirmed inoperable stage III NSCLC, suitable for the treatment of CCRT

Inclusion criteria

  • untreated pathologically confirmed inoperable stage III NSCLC according to the 8th edition of the American Joint Committee on Cancer staging system;
  • at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)1.1;
  • 18-75 years of age;
  • Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1;
    1. FEV1>1.0 L;
  • suitable function of bone marrow, liver, kidney and coagulation

Exclusion criteria

Exclusion Criteria:

history of other malignant diseases, uncontrolled hypertension, any contraindications to chemoradiotherapy, pregnancy, breastfeeding or preexisting bleeding diatheses.

-

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. PFS

    progress free survival

    Time frame: 15 months

Secondary outcomes

  1. OS

    Overall survival

    Time frame: 3 years

  2. LRFS

    Locoregional relapse-free survival

    Time frame: 2 years

  3. DMFS

    Distant metastasis-free survival

    Time frame: 2 years

  4. AEs

    adverse events

    Time frame: 3 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — Only principlal investigator has the right to use all the data collected. The individual participant will not be allowed to share the data among them.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04161352
Lead sponsor
Zhejiang Cancer Hospital
Responsible party
Sponsor
First posted
Nov 13, 2019
Start date
Nov 25, 2019 (estimated)
Primary completion
Jun 30, 2022 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Nov 13, 2019

Study contacts

Ming Chen, Doctor
Contact
chenming@zjcc.org.cn
18758875572
Honglian Ma, Doctor
Contact
mahl@zjcc.org.cn
18758871656

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

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