AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaPhase 2NCT06122493

Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Tirelizumab, Nab paclitaxel and Carboplatin in people with Esophageal Squamous Cell Carcinoma, run by Ruijin Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This study aims to investigate a comprehensive therapeutic approach for patients with unresectable esophageal squamous cell carcinoma, clinically staged as Tany, N3, M0, and who are not candidate for concurrent chemoradiotherapy combined with immunotherapy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Tirelizumab, Nab paclitaxel and Carboplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
1 Nov 2022to 1 Nov 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Esophageal squamous cell carcinoma confirmed through histopathology.
  • Distant metastasis excluded by CT, MRI, or PET/CT examinations.
  • Locally advanced stage: AJCC/UICC eighth edition staging with any T, N3M0.
  • Expected survival time of at least 6 months.
  • With an ECOG performance status of 0 to 2. Not accompanied by severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease, or other comorbidities that could impact radiotherapy progress.
  • Adequate function of major organs: Hematopoietic function: Hemoglobin ≥100g/L, platelets ≥90×109/L, white blood cells ≥4×109/L. Exceptions may be considered for patients with ECOG 0-1 who have a history of chronic anemia (80-100 g/L), previous low white blood cell levels (3-4×109/L), or reduced platelets (80-90×109/L). Liver function: ALT and AST <1.5 times the upper limit of normal (ULN), bilirubin <1.5×ULN. Renal function: Serum creatinine (SCR) ≤140 μmol/L.
  • Patients are required to provide informed consent to undergo treatment.

Who cannot join

  • Existing or prior history of other malignant tumors (except non-melanoma skin cancer) that are uncontrolled or not cured, depending on the type of the primary tumor.
  • Lack of histological or cytological diagnosis for esophageal cancer.
  • Previous chest radiotherapy.
  • Suffering from innate or acquired immune function defects;
  • Pregnancy (confirmed by serum or urine β-HCG test) or during the lactation period; History of drug abuse or alcohol dependence; HIV-positive status, including those on antiretroviral treatment; Chronic hepatitis B with viral replication phase; Active phase of hepatitis C; Active syphilis with a history of mental illness that may hinder treatment completion.
  • Poor overall health status, defined as KPS < 70 or ECOG > 2.
Show all 9Show fewer
  • Presence of severe comorbidities that could impact radiotherapy progress, including: Unstable angina, congestive heart failure, or myocardial infarction requiring hospitalization within the past 6 months; Acute bacterial or systemic fungal infections; Exacerbation of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization; Hepatic or renal insufficiency; Immunosuppressed patients; Coexisting connective tissue diseases, such as active scleroderma or lupus, which are contraindications to radiotherapy.
  • Inability to comprehend the treatment's purpose or unwillingness to sign the treatment consent form.
  • Lack of legal capacity or limited legal capacity.

Trial locations and contacts

1 site in 1 country.

Yifeng Wang contact

0086-021-64370045

ruijincrc@126.com

China1 site, 1 recruiting

  • Ruijin hospital, Shanghai jiaotong university school of medicine

    Shanghai, Shanghai Municipality, 200025

    Shengguang Zhao

    Shengguang Zhao

    Recruiting

Other trials in China

About this study

Official title: Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma: a Phase Ⅱ Single Arm Prospective Study

This study aims to investigate a comprehensive therapeutic approach for patients with unresectable esophageal squamous cell carcinoma, clinically staged as Tany, N3, M0, and who are not candidate for concurrent chemoradiotherapy combined with immunotherapy. The approach entails combining chemotherapy with immune therapy, followed by synchronized radiotherapy during the immune maintenance phase. The primary goal is to mitigate treatment-related side effects and enhance the overall prognosis through the integration of these treatment modalities.

Read the detailed description

Eligible ESCC patients receive a four-cycle regimen of combined chemotherapy plus immunotherapy. Those without disease progression then get definitive radiotherapy with immune maintenance therapy for up to 12 months.

Being tested
Tirelizumab, Nab paclitaxel, Carboplatin, Radiotherapy
Keywords
ESCC, cN3, radiotherapy, chemotherapy, immunotherapy
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.

  • TirelizumabDrug

    Also called anti-PD-1 monoclonal antibody

    immunotherapy, 200 mg on day 1 per 3 weeks

  • Nab paclitaxelDrug

    Also called Chemotherapy drug

    chemotherapy, 175 mg/m² on day 1 per 3 weeks

  • CarboplatinDrug

    Also called Chemotherapy drug

    chemotherapy, AUC=5 on day 1 per 3 weeks

  • RadiotherapyRadiation

    Also called Locoregional therapy

    Patients without disease progression after four cycles of chemoimmunotherapy receive radiotherapy targeting esophageal lesions and positive lymph nodes, with a total dose of 50.4 Gy delivered over 28 fractions.

Study groups in NCT06122493
Study groupRoleWhat they receive
chemotherapy-immunotherapy-radiotherapyOtherCarboplatin (AUC = 5, d1) and nab-paclitaxel (175 mg/m², day1) will be administered every 3 weeks for four cycles.Tislelizumab (200 mg) will be administered every 3 weeks for up to 12 months. Radiotherapy targeting esophageal lesions and positive lymph nodes, with a total dose of 50.4 Gy over 28 fractions will be delivered.
Receives: Drug: Tirelizumab; Drug: Nab paclitaxel; Drug: Carboplatin; Radiation: Radiotherapy

What is being measured

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

  1. 1-year progression-free survival

    From the initial administration of the study drug to the first identification of disease progression or mortality, whichever happens first. In the case of patients who had not encountered local control failure or death, specifically in terms of progression-free survival, the time of the last tumor assessment was considered as the endpoint. Tumor response was evaluated by investigators following RECIST v1.1 criteria.

    Measured: 1 year

Secondary outcomes (7)

  1. Acute toxicity

    Monitor the occurrence of acute toxic reactions (based on CTCAE4.03) and subacute toxic reactions (RTOG) in the treatment of cN3 ESCC with the combination of chemotherapy, immunotherapy, and ongoing radiotherapy, both during the treatment course and within three months after its completion.

    Measured: 3 months

  2. Quality of Life (QoL)

    Collect QoL data on cN3 ESCC patients. The data is measured by EORTC QLQ-C30 (Version 3.0) according to investigator collection at the starting and ending time of the treatment. EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The core and disease-specific for ESCC modules are selected to estimate treatment related influence on patients' life. The final score of the questionnaire is collected and analyzed according to detailed scoring procedures from manuals.

    Measured: 1 years

  3. Objective response rate

    Defined as the proportion of patients with complete response (CR) or partial response (PR)

    Measured: 1 year

  4. Duration of response

    Defined as the period from the recognition of an objective response to the first identification of either progression or death, whichever event transpired first.

    Measured: 1 year

  5. Disease control rate

    Defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD)

    Measured: 1 year

  6. Immune Progression Free Survival

    defined as the duration from the initial dose of tislelizumab to the first identification of either disease progression or death, whichever happens first. Tumor response was evaluated by investigators following iRECIST criteria.

    Measured: 1 year

  7. Overall survival

    defined as the period from the initial drug administration to the subject's demise from various causes. In cases where patients were lost to follow-up prior to their passing, the date of their last documented contact was documented. For patients still alive at the last analyzed time point, the time of their last contact was considered as their survival duration. In the analysis of survival and subsequent treatment, all patients were monitored until their death, loss to follow-up, or the conclusion of the study.

    Measured: 1 year

Timeline

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

  1. First posted8 Nov 2023
  2. Study start1 Nov 2022
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 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
Model description
Chemotherapy includes carboplatin (AUC = 5, d1) and nab-paclitaxel (175 mg/m², day1) every 3 weeks for four cycles. Simultaneously, immunotherapy with tislelizumab (200 mg) is integrated into the treatment plan for these cycles. After the initial four cycles, patients have physical exams and imaging. Those with SD, PR, or CR receive radiotherapy targeting esophageal lesions and positive lymph nodes, with a total dose of 50.4 Gy over 28 fractions. During radiotherapy, two additional cycles of immunotherapy with tislelizumab are given at three-week intervals. After radiotherapy, patients continue with maintenance treatment, taking tislelizumab every three weeks. This maintenance therapy lasts up to a year, or until disease progression or intolerance develops.
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06122493
Sponsor's protocol ID
RuijinH 2022(270)
Status last verified
Oct 2023
First submitted
18 Oct 2023
Last updated
8 Nov 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 Tirelizumab, Nab paclitaxel and Carboplatin in people with Esophageal Squamous Cell Carcinoma, run by Ruijin Hospital at 1 site 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 7 inclusion and 9 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 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Yifeng Wang (0086-021-64370045, ruijincrc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year progression-free survival (time frame: 1 year). 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 NCT06122493.

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 8 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in