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Esophageal Squamous Cell CarcinomaPhase 2NCT03857763

A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Apatinib,Paclitaxel,Cisplatin,RT in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to assess the efficacy and safety of apatinib plus concurrent neoadjuvant chemoradiotherapy in patients with esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Apatinib,Paclitaxel,Cisplatin,RT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 Mar 2019to 1 Mar 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age:18 to 70 years old (man or female);
  • Pathologically diagnosed with esophageal squamous cell carcinoma;
  • Patients with Stage for Ⅱ-Ⅲ(T2-4N0/+M0) (According to transesophageal ultrasonography;
  • Patients with measurable lesions(According to the criteria in RECIST1.1);
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • Life expectancy greater than or equal to 3 months;
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  • Major organ function has to meet the following certeria:
  • For results of blood routine test
  • HB≥80g/L;
  • ANC≥1.5×109/L;
  • PLT≥90×109/L; (2) For results of blood biochemical test
  • ALT and AST≤2.5×ULN; b) TBIL<1.5×ULN; c) Serum creatinine ≤1.5×ULN; 8. Doctors believe that treatment can bring benefits to patients; 9. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Who cannot join

  • Have received prior treatment with chemotherapy or radiotherapy；
  • Have high blood pressure and antihypertensive drug treatment can not control;
  • Patients with severe cardiovascular disease ;
  • Accompanied by esophageal perforation and esophagotracheal fistula;
  • Patients with active bleeding or bleeding tendency;
  • Pregnant or lactating women;
  • The researchers think inappropriate.

About this study

The purpose of this study is to assess the efficacy and safety of apatinib plus concurrent neoadjuvant chemoradiotherapy in patients with esophageal squamous cell carcinoma.

Being tested
Apatinib,Paclitaxel,Cisplatin,RT
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apatinib,Paclitaxel,Cisplatin,RTCombination product

    Apatinib Mesylate Tablets 250mg qd p.o. d1-35; Paclitaxel：50mg/m2 iv d1，8，15，22，29; Cisplatin: 30mg/m2 iv d1，8，15，22，29; RT：41.4Gy/23f , 1.8Gy/f，5 f/w

Study groups in NCT03857763
Study groupRoleWhat they receive
Apatinib+Paclitaxel+Cisplatin+RTExperimentalApatinib：250mg,po,qd, d1-35; Paclitaxel：50mg/m2 iv, d1，8，15，22，29; Cisplatin: 30mg/m2 iv, d1，8，15，22，29; Radiotherapy：41.4Gy/23f , 1.8Gy/f，5 f/w
Receives: Combination Product: Apatinib,Paclitaxel,Cisplatin,RT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The pathological complete response rate(pCR)

    The lesion disappeared completely by pathology

    Measured: within 3 weeks after surgery

Secondary outcomes (4)

  1. R0-resection rate

    There was no residual by the microscope

    Measured: within 3 weeks after surgery

  2. Disease-free survival(DFS)

    Baseline to measured date of recurrence or death from any cause

    Measured: 3 years

  3. Overall survival (OS)

    Baseline to measured date of death from any cause

    Measured: 1year

  4. Adverse events Toxicity

    Adverse events Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2019
  2. Study start1 Mar 2019 (estimated)
  3. Primary completion1 Mar 2020 (estimated)
  4. Study completion1 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03857763
Sponsor's protocol ID
HBAE-01
Status last verified
Feb 2019
First submitted
26 Feb 2019
Last updated
28 Feb 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib,Paclitaxel,Cisplatin,RT in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The pathological complete response rate(pCR) (time frame: within 3 weeks after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03857763.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.

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