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Esophageal Squamous Cell CarcinomaPhase 2NCT02649361

Study of Anlotinib in Patients With Esophageal Squamous Cell Carcinoma (ALTER1102)

A Phase 2 study testing Anlotinib in people with Esophageal Squamous Cell Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 18 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare the effects and safety of Anlotinib with placebo in patients with esophageal squamous cell carcinoma(ESCC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Anlotinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
164 participants
Where
18 sitesChina
Study dates
Jan 2016to 23 Jul 2018
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological documentation of esophageal squamous cell carcinoma；
  • Advanced esophageal squamous cell carcinoma with distant metastasis(Stage IV),at least one measurable lesion (by RECIST1.1)
  • Patients who at least have failed to a platinum-based chemotherapy treatment or chemotherapy containing paclitaxel.
  • Note: (1) Each line treatment refers to treatment duration at least one cycle using monotherapy or drug combination; (2)Adjuvant chemotherapy or neoadjuvant chemoradiation is permitted before the study (if disease recurred during adjuvant chemotherapy/neoadjuvant chemoradiation or recurred within 6 months after stopping treatment, adjuvant chemotherapy/neoadjuvant chemoradiation can be considered as first line systemic chemotherapy;
  • 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months
  • 4 weeks or more from the last cytotoxic therapy, radiation therapy or surgery
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  • Main organs function is normal
  • Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
  • Patients should participate in the study voluntarily and sign informed consent

Who cannot join

  • Patients whose primary lesion with active bleeding within 2 months
  • Primary lesion not resected and has not shrinked after radiation therapy
  • Patients who have been failure with anti-tumor angiogenesis drug treatment
  • Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
  • Brain metastases patients with symptoms or symptoms controlled < 3 months
  • Patients with any severe and/or unable to control diseases，including：
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  • Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
  • Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
  • Patients with active or unable to control serious infections;
  • Patients with cirrhosis, decompensated liver disease, or active hepatitis;
  • Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
  • Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed
  • Patients with non-healing wounds or fractures
  • Patients with any CTC AE Grade 1 or higher bleeding events occurred in the lungs or any CTC AE Grade 2 or higher bleeding events occurred within 4 weeks prior to assignment;Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation
  • Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism
  • Patients with drug abuse history and unable to get rid of or Patients with mental disorders
  • Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage
  • Patients participated in other anticancer drug clinical trials within 4 weeks
  • History of immunodeficiency
  • Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Hunan Cancer Hospital

    Changsha, Hunan

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Harbin medical university affiliated tumor hospital

    Harbin, Heilongjiang

  • Shandong Cancer Hospital

    Jinan, Shandong

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

  • Tianjin Medical University Cancer Hospital

    Tianjin, Tianjin Municipality

  • Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • The First Affiliated Hospital of Xian Jiaotong University

    Xian, Shanxi

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Esophageal Squamous Cell Carcinoma(ALTER1102)

To compare the effects and safety of Anlotinib with placebo in patients with esophageal squamous cell carcinoma(ESCC).

Being tested
Anlotinib, Placebo
Keywords
Anlotinib
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.

  • AnlotinibDrug

    Anlotinib p.o. qd

  • PlaceboDrug

    Placebo p.o. qd

Study groups in NCT02649361
Study groupRoleWhat they receive
AnlotinibExperimentalAnlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Receives: Drug: Anlotinib
PlaceboPlacebo comparatorPlacebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Receives: Drug: Placebo

What is being measured

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

  1. Progress free survival (PFS)

    Measured: From randomization，each 42 days up to PD or death(up to 24 months)

Secondary outcomes (3)

  1. Overall Survival (OS)

    Measured: From randomization until death (up to 24 months)

  2. Objective Response Rate (ORR)

    Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)

  3. Disease Control Rate (DCR)

    Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)

Timeline

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

  1. First posted7 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completion23 Jul 2018
  4. Study completion23 Jul 2018

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02649361
Sponsor's protocol ID
ALTN-11-II
Status last verified
Jun 2019
First submitted
6 Jan 2016
Last updated
5 Jun 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Huang J, Xiao J, Fang W, Lu P, Fan Q, Shu Y, Feng J, Zhang S, Ba Y, Zhao Y, Liu Y, Bai C, Bai Y, Tang Y, Song Y, He J. Anlotinib for previously treated advanced or metastatic esophageal squamous cell carcinoma: A double-blind randomized phase 2 trial. Cancer Med. 2021 Mar;10(5):1681-1689. doi: 10.1002/cam4.3771. Epub 2021 Feb 14.

    PubMed 33586360

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib in people with Esophageal Squamous Cell Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 18 sites in China.

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 9 inclusion and 20 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: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progress free survival (PFS) (time frame: From randomization，each 42 days up to PD or death(up to 24 months)). 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 NCT02649361, which also lists 1 linked publication.

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 5 Jun 2019.

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