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Esophageal CarcinomaPhase 2NCT05996484

Neoadjuvant Therapy of Anlotinib Combined With Toripalimab and Chemotherapy for Resectable Esophageal Carcinoma

A Phase 2 study testing Toripalimab, Anlotinib hydrochloride and Albumin paclitaxel in people with Esophageal Carcinoma and Neoadjuvant Therapy, run by Nanfang Hospital, Southern Medical University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 explore the effectiveness and safety of the combination of Anlotinib, Toripalimab, and albumin-bound paclitaxel with cisplatin for neoadjuvant therapy in resectable esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Carcinoma, Neoadjuvant Therapy
What is being tested?
Toripalimab, Anlotinib hydrochloride and Albumin paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
No sites listed yet
Study dates
Sep 2023to Jul 2026
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

  • Age range: 18-70 years, both male and female.
  • Patients with histopathological diagnosis of esophageal squamous cell carcinoma confirmed by gastroscopy/ultrasound gastroscopy, and clinical diagnosis of cT2N1-2M0 or cT3N0-2M0, with TNM staging of stage II-III B.
  • Non-cervical esophageal cancer patients.
  • No prior systemic or local treatment for esophageal cancer, with at least one measurable lesion for imaging evaluation of neoadjuvant therapy according to RECIST 1.1 criteria.
  • ECOG PS (Eastern Cooperative Oncology Group Performance Status): 0-1.
  • Estimated survival period ≥12 months.
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  • Subjects without significant dysfunction of major organs, with normal assessment of thyroid, lung, liver, kidney, and cardiac function.
  • Reproductive-age women must have taken reliable contraceptive measures or undergone pregnancy testing (serum or urine) within 7 days prior to enrollment, with negative results, and be willing to use appropriate contraception during the trial and for 8 weeks after the last administration of the investigational drug. For males, they must agree to use appropriate contraception during the trial and for 8 weeks after the last administration of the investigational drug, or have undergone surgical sterilization.
  • Subjects voluntarily participate in this study, sign an informed consent form, demonstrate good compliance, adhere to the planned schedule for regular clinical follow-up and necessary treatment, and cooperate in obtaining regular blood and tissue samples.

Who cannot join

  • Patients who have had or currently have other malignant tumors within the past 1.5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades lamina propria)].
  • Patients with ulcerative esophageal squamous cell carcinoma.
  • Patients with esophageal fistula or tracheal fistula.
  • Patients allergic to anlotinib, toripalimab, or albumin-bound paclitaxel.
  • Patients with a history of immunodeficiency diseases, including HIV-positive patients or those with other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
  • Patients with severe and/or uncontrolled diseases are excluded from the study, including:
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  • 6.1 Patients with unsatisfactory blood pressure control (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mmHg).
  • 6.2 Patients with grade I or higher myocardial ischemia or myocardial infarction.
  • 6.3 Patients with arrhythmia (including QT interval ≥480 ms) and grade I heart failure.
  • 6.4 Patients with poorly controlled diabetes (fasting blood glucose >10 mmol/L) or receiving high-dose glucocorticoid therapy.
  • 6.5 Patients with active or uncontrolled severe infections. 6.6 Patients with decompensated liver disease, active hepatitis B (HBV-DNA ≥10^4 copies/ml or 2000 IU/ml), or hepatitis C (positive for hepatitis C antibodies and HCV RNA) exceeding the lower limit of the analytical method.
  • 6.7 Patients with hyperthyroidism or hypothyroidism. 6.8 Patients with active tuberculosis.
  • Unresolved toxicities of grade 2 or higher, excluding alopecia, caused by any prior treatment.
  • Individuals with multiple factors that affect oral medication administration, such as dysphagia, chronic diarrhea, and intestinal obstruction.
  • Individuals with urine routine showing urinary protein ≥++, and confirmed 24-hour urine protein quantification >1.0 g.
  • Individuals who underwent major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to randomization.
  • Abnormal coagulation function: INR >1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN, with a bleeding tendency or receiving thrombolytic or anticoagulation therapy. Patients who experienced any bleeding or hemorrhagic events ≥ grade 3 CTCAE within 4 weeks prior to randomization, with unhealed wounds, ulcers, or fractures.
  • Occurrence of arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism.
  • Pregnant or lactating women.
  • Presence of distant metastasis.
  • Patients with significant bone marrow suppression.
  • Patients with mental illness or a history of substance abuse with psychotropic drugs.
  • Patients who participated in other drug clinical trials within 4 weeks.
  • Patients with accompanying diseases that, in the investigator's judgment, pose a serious risk to patient safety or may affect the patient's completion of the study.
  • Patients with inherited bleeding tendencies, coagulation disorders, potential invasion of major blood vessels, and other bleeding risks, who experienced clinically significant bleeding symptoms or had a clear bleeding tendency with gastrointestinal bleeding, bleeding gastric ulcers, baseline fecal occult blood ++ and above within 3 months prior to enrollment.
  • Patients deemed unsuitable

Trial locations and contacts

No sites are listed yet.

di lu, M.D., PhD contact

13268379321

david_lu1989@163.com

About this study

Official title: Anlotinib in Combination With Toripalimab and Chemotherapy for Neoadjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma: a Phase II Clinical Study

The purpose of this study is to explore the effectiveness and safety of the combination of Anlotinib, Toripalimab, and albumin-bound paclitaxel with cisplatin for neoadjuvant therapy in resectable esophageal squamous cell carcinoma. The study aims to improve the pathological complete response rate (pCR), R0 resection rate, and disease-free survival (DFS) in patients undergoing esophageal cancer surgery. The findings of this study will provide guidance and new options for the treatment of locally advanced esophageal cancer patients.

Read the detailed description

Both anti-angiogenic therapy and immune checkpoint inhibitors have shown preliminary efficacy and safety data in the field of neoadjuvant therapy for esophageal cancer. However, there is currently no available data on the combination of immune checkpoint inhibitors, anti-angiogenic therapy, and chemotherapy in neoadjuvant therapy for esophageal cancer. Based on the favorable survival benefits of this combination in first-line and second-line treatments for multiple tumors, we aim to explore another neoadjuvant treatment approach - adding anti-angiogenic agents to immune checkpoint inhibitor-based neoadjuvant therapy, providing a new perioperative treatment strategy for esophageal cancer.

Being tested
Toripalimab, Anlotinib hydrochloride, Albumin paclitaxel, Cisplatin
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • ToripalimabDrug

    Also called JS001

    Toripalimab, 240mg, IV., D1, every 3 weeks, 4 cycles.

  • Anlotinib hydrochlorideDrug

    Also called Anlotinib

    Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off, every 3 weeks, 4 cycles.

  • Albumin paclitaxelDrug

    Also called Paclitaxel For Injection (Albumin Bound)

    Albumin paclitaxel, 200-260 mg/m2, IV., D1, every 3 weeks, 4 cycles.

  • CisplatinDrug

    Also called CDDP

    Cisplatin, 60-75 mg/m2, IV., D1, every 3 weeks, 4 cycles.

Study groups in NCT05996484
Study groupRoleWhat they receive
Neoadjuvant Anlotinib Combined With Toripalimab and ChemotherapyExperimentalToripalimab+ Anlotinib+Albumin-bound paclitaxel+Cisplatin
Receives: Drug: Toripalimab; Drug: Anlotinib hydrochloride; Drug: Albumin paclitaxel; Drug: Cisplatin

What is being measured

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

  1. Pathologic complete remission (PCR)

    Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell

    Measured: Immediately after the surgery

Secondary outcomes (7)

  1. R0 resection rate

    Residual tumor rate

    Measured: Immediately after the surgery

  2. Objective response rate (ORR)

    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Measured: Up to 36 month

  3. Disease control rate (DCR)

    DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease (SD) per RECIST 1.1.

    Measured: Up to 36 month

  4. Disease-free survival (DFS)

    Survival without local or systemic recurrence

    Measured: 3(5) years after last patient enrolled

  5. Overall survival (OS)

    Overall survival is defined as the duration from date of enrollment to the date of death from any cause.

    Measured: Up to 36 month

  6. Safety: AE

    Safety was defined as the Number of Participants With an Adverse Event

    Measured: Up to 36 month

  7. Change From Baseline in HRQoL Score Using EORTC Quality of Life Questionnaire-Oesophageal Module (QLQ-OES18)

    The EORTC QLQ-OES18 is a disease-specific questionnaire to assess measurements specific to esophageal cancer. It contains 18 items and is based on four subscales-dysphagia, eating, reflux and pain. All items are scored using a four-point scale that offers these response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. A higher score indicates worse level of symptoms. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in HRQoL QLQ-OES18 score in participants will be presented.

    Measured: Up to 36 month

Timeline

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

  1. First posted18 Aug 2023
  2. Study startSep 2023 (estimated)
  3. Primary completionNov 2024 (estimated)
  4. Study completionJul 2026 (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
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05996484
Sponsor's protocol ID
NFEC-2023-310
Status last verified
Aug 2023
First submitted
10 Aug 2023
Last updated
21 Aug 2023
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 Toripalimab, Anlotinib hydrochloride and Albumin paclitaxel in people with Esophageal Carcinoma and Neoadjuvant Therapy, run by Nanfang Hospital, Southern Medical University.

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 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 21 Aug 2023. 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?

Contact di lu, M.D., PhD (13268379321, david_lu1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic complete remission (PCR) (time frame: Immediately after the 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 NCT05996484.

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 21 Aug 2023.

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