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Esophageal Squamous Cell CarcinomaPhase 2NCT04063683

Paclitaxel and DDP Combined With Anlotinib in the First-line Treatment for Patients With Advanced Esophageal Squamous Cell Carcinoma（ESCC）.

A Phase 2 study testing Anlotinib Hydrochloride, Paclitaxel, cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Henan Cancer Hospital at 6 sites in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the efficacy and safety of paclitaxel and DDP combined with Anlotinib in the treatment of advanced esophageal squamous cell carcinoma. 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 Hydrochloride, Paclitaxel, cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
6 sitesChina
Study dates
7 Oct 2019to Jun 2022
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

  • histopathology confirmed unresectable, locally recurrent or metastatic advanced esophageal squamous cell carcinoma (excluding mixed type adenosquamous carcinoma );
  • Those who have not received systemic treatment before, or who relapsed after (new) adjuvant therapy/radical surgery more than 6 months ; Note: Including advanced or recurrent Patients who ever received only radiotherapy on non-target lesions. The duration from the end of palliative treatment for local lesions (non-target lesions) to enrollment should > 2 weeks;
  • According to RECIST 1.1, at least one measurable lesion; the measurable lesions should not have received local treatment such as radiotherapy (for the lesions in the area where received local radiotherapy, it can also be regarded as a target lesion if confirmed to progress according to the recist1.1);
  • Age from 18-75 years old;
  • ECOG PS score: 0-1; expected survival time more than 3 months;
  • 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 3 months after study is stopped；the result of serum or urine pregnancy test should be negative before enrollment；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 2 months after study is stopped.
  • Patients should participate in the study voluntarily and sign informed consent

Who cannot join

  • Patients tends to have complete obstruction or patients requiring interventional treatment for obstruction;
  • ulcerated esophageal squamous cell carcinoma patients;
  • after esophageal or endotracheal stent implantation;
  • Patients with a high risk of bleeding or perforation due to the apparent invasion of adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed fistulas;
  • patients with ESCC who have not undergone surgical resection but have not reduced esophageal lesions after radiotherapy;
  • allergic to paclitaxel and cisplatin preparations or excipients;
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  • Adjuvant chemotherapy patients who have used paclitaxel or cisplatin, and relapse or metastasize within one year;
  • A variety of factors affecting oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
  • The of liver metastases accounts for more than 50% of the total liver volume;
  • patients with any severe and / or uncontrolled disease, including:Unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmhg or diastolic blood pressure ≥100) Mmhg) patients; patients with grade ≥ myocardial ischemia or myocardial infarction, arrhythmia (including qt interval ≥ 480ms); according to nyha criteria, iii-iv cardiac dysfunction, or cardiac ultrasonography prompted left ventricular ejection fraction (lvef) <50% of patients;live Severe infection that is sexual or uncontrolled;Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis;poor diabetes control (fasting blood glucose (fbg)>10mmol/l);Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0 g;
  • long-term unhealed wounds or fractures;
  • Patients with active hemorrhage within 2 months of primary lesions; pulmonary hemorrhage with NCI CTC AE grade >1, 4 weeks before of enrollment; other sites of bleeding NCI CTC AE grade >2, 4 weeks before of enrollment; patients with bleeding tendency (such as active gastrointestinal ulcers) or patients undergoing thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues;
  • Have undergone major surgery (craniotomy, thoracotomy or open surgery) within 4 weeks prior to the first dose study or Major surgery is required during the study period.
  • A history of gastrointestinal perforation and/or fistula occurred within 6 months prior to treatment; or an overactive/venous thrombosis event such as a cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and lung Embolism.
  • Symptomatic central nervous system metastasis and/or cancerous meningitis are known to exist;
  • Clinically significant ascites, including any ascites that can be found on a physical examination, ascites that has been treated or currently in need of treatment, and only those with a small amount of ascites but no symptoms can be selected;
  • A moderate amount of fluid in both sides of the chest, or a large amount of fluid in one side of the chest, or has caused respiratory dysfunction Patient to be drained;
  • known to have active tuberculosis;
  • suffering from interstitial lung disease requiring steroid therapy;
  • Uncontrolled metabolic disorders or other non-malignant tumors or systemic diseases or cancer secondary reactions that can lead to higher medical risks and/or survival Evaluation of uncertainty;
  • Significantly malnourished patients;
  • those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder;
  • A history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
  • History of other primary malignancies, but the following : 1) complete remission of malignant tumors for at least 2 years prior to enrollment and no additional treatment during the study; 2) non-melanoma skin cancer or malignant freckle-like sputum with adequate treatment and no evidence of disease recurrence; 3) adequately treated and In situ carcinoma without evidence of disease recurrence;
  • Female patients who are pregnant or breastfeeding
  • According to the investigator's judgment, there are serious concomitant diseases that endanger the safety of the patient or affect the patient's completion of the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • ANYANG Cancer Hospital

    Anyang, Henan, 455000

  • Qilu Hospital

    Jinan, Shandong

  • Shandong Cancer Hospital

    Jinan, Shandong

  • Linyi Central Hospital

    Linyi, Shandong

  • First Affiliated Hospital of Henan University of Science and Technolog

    Luoyan, Henan

  • Henan cancer hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: Paclitaxel and DDP Combined With Anlotinib in the First-line Treatment for Patients With Advanced Esophageal Squamous Cell Carcinoma: a Single Arm, Multicentre Trial.

To evaluate the efficacy and safety of paclitaxel and DDP combined with Anlotinib in the treatment of advanced esophageal squamous cell carcinoma.

Being tested
Anlotinib Hydrochloride, Paclitaxel, cisplatin
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.

  • Anlotinib Hydrochloride, Paclitaxel, cisplatinDrug

    • anlotinib: 1 capsule (10mg) once a day, d1-d14 per cycle, 3 weeks for a treatment cycle.
    • Paclitaxel: intravenously infused at 135mg/ m2, administered d1 per cycle, 3 weeks for a treatment cycle.
    • Cisplatin: administered after paclitaxel, intravenously infused at 60-75 mg/m2, divided into d1-d3 medications per cycle; 3 weeks for one treatment cycle.
Study groups in NCT04063683
Study groupRoleWhat they receive
Anlotinib with chemotherapyExperimentalNot described
Receives: Drug: Anlotinib Hydrochloride, Paclitaxel, cisplatin

What is being measured

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

  1. Progress free survival (PFS)

    Measured: From first treatment，each 42 or 63 days until PD or death(up to 24 months)

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    Measured: each 42 or 63 days until intolerant the toxicity or PD (up to 24 months) ]

  2. Disease Control Rate (DCR)

    Measured: each 42 or 63 days until intolerant the toxicity or PD (up to 24 months) ]

  3. Duration of Response(DOR)

    Measured: each 42 or 63 days until intolerant 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 posted21 Aug 2019
  2. Study start7 Oct 2019
  3. Primary completionMar 2022 (estimated)
  4. Study completionJun 2022 (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
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04063683
Sponsor's protocol ID
2019315
Status last verified
Aug 2021
First submitted
19 Aug 2019
Last updated
24 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Li N, Wu T, Hong YG, Guo YZ, Cheng YF, Ma YJ, Bie LY, Cui DH, Gao XH, Tan BX, Li BS, Luo SX, Wang JS. A multi-center, single-arm, phase II study of anlotinib plus paclitaxel and cisplatin as the first-line therapy of recurrent/advanced esophageal squamous cell carcinoma. BMC Med. 2022 Dec 8;20(1):472. doi: 10.1186/s12916-022-02649-x.

    PubMed 36482345

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib Hydrochloride, Paclitaxel, cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Henan Cancer Hospital at 6 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 8 inclusion and 26 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 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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. 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?

Progress free survival (PFS) (time frame: From first treatment，each 42 or 63 days until 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 NCT04063683, 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 24 Aug 2021.

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