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Esophageal Squamous Cell CarcinomaNCT05740995

Neoadjuvant Anti-PD-1 Plus Chemotherapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

An observational study of Esophageal Squamous Cell Carcinoma and Neoadjuvant Chemoimmunotherapy, run by Shanghai Zhongshan Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the outcomes and identify predictors of neoadjuvant anti-PD-1 plus chemotherapy in locally advanced resectable esophageal squamous cell carcinoma (ESCC). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
neoadjuvant anti-PD-1 plus chemotherapy
Type of treatment
Injection or infusion
How many people
40 participants
Where
1 siteChina
Study dates
1 Dec 2020to Dec 2028
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Patients with locally advanced resectable ESCC (cT3-4aN0-1M0)

Who may be able to join

  • Histologically-confirmed squamous cell carcinoma of the esophagus;
  • Tumors of the esophagus are located in the thoracic cavity;
  • Pre-treatment stage as cT3-4aN0-1M0 (AJCC/UICC 7th Edition) (In case of stage cT4a, curative resectability has to be explicitly verified by the local surgical investigator prior to randomization).
  • Age is between 18 years and 75 years,
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  • Adequate cardiac function. All patients should perform ECG, and those with a cardiac history or ECG abnormality should perform echocardiography with the left ventricular ejection fraction > 50 %;
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  • Adequate respiratory function with FEV1≥1.2L, FEV1%≥50% and DLCO≥50% shown in pulmonary function tests;
  • Adequate bone marrow function (White Blood Cells >4x10^9 /L; Neutrophil >2.0×10^9 /L; Hemoglobin > 90 g/L; platelets>100x10^9 /L);
  • Adequate liver function (Total bilirubin <1.5x Upper Level of Normal (ULN); Aspartate transaminase(AST) and Alanine transaminase (ALT)<1.5x ULN);
  • Adequate renal function (Glomerular filtration rate (CCr) >60 ml/min; serum creatinine (SCr) ≤120 µmol/L);
  • The patient has provided written informed consent and is able to understand and comply with the study;

Who cannot join

  • Patients with non-squamous cell carcinoma histology;
  • Patients with advanced inoperable or metastatic esophageal cancer;
  • Pre-treatment stage as cT1-2N0-1M0 (AJCC/UICC 7th Edition);
  • Pre-treatment stage as cN2-3 or cT4b(non-curatively-resectable verified by the local surgical investigator, AJCC/UICC 7th Edition);
  • Patients with another previous or current malignant disease which is likely to interfere with treatment or the assessment of response in the judgement of the local surgical investigator.
  • Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months), clinically-significant lung disease, clinically-significant bone marrow, liver, renal function disorder;
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  • Pregnant or lactating women and fertile women who will not be using contraception during the trial;
  • Allergy to any drugs;
  • Participation in another intervention clinical trial with interference to the therapeutic intervention during this study or during the last 30 days prior to informed consent;
  • Expected lack of compliance with the protocol.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jie Gu, MD contact

+86 13611972978

gu.jie3@zs-hospital.sh.cn

Di Ge, MD contact

ge.di@zs-hospital.sh.cn

China1 site, 1 recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Di Ge, PhD, ge.di@zs-hospital.sh.cn

    Jie Gu, PhD, gu.jie3@zs-hospital.sh.cn

    Recruiting

Other trials in China

About this study

Official title: A Single-center, Prospective Cohort Study of Neoadjuvant Anti-PD-1 Plus Chemotherapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

The purpose of this study is to evaluate the outcomes and identify predictors of neoadjuvant anti-PD-1 plus chemotherapy in locally advanced resectable esophageal squamous cell carcinoma (ESCC). In this single-center cohort study, we are aiming to (1) evaluate the therapeutic efficacy and survival benefits on patients with locally advanced resectable ESCC (cT3-4aN0-1M0); (2) evaluate the value of genomic indicators including MMR alternation status in predicting therapeutic responses and prognosis; (3) evaluate the value of transcriptomic indicators including B cell lineage features in predicting therapeutic responses and prognosis; (4) evaluate the value of microbial and metabolite indicators in predicting therapeutic responses and prognosis. Whole exome sequencing, RNA sequencing, 16S rRNA sequencing and Liquid Chromatography with tandem mass spectrometry (LC-MS-MS) of samples of patients to neoadjuvant chemoimmunotherapy before and after treatment are performed to explore the mechanisms of drug resistance and identification of predictive and prognosis biomarkers.

Read the detailed description

Multiple clinical trials investigated the safety and feasibility of neoadjuvant anti-PD-1 plus chemotherapy in esophageal squamous cell carcinoma (ESCC). However, the efficacy of neoadjuvant chemoimmunotherapy was undetermined and existing biomarkers failed to provide stable prediction of therapeutic responses. This study seek to further evaluate the clinical outcomes and identify biological predictors of neoadjuvant anti-PD-1 plus chemotherapy in locally advanced resectable esophageal squamous cell carcinoma (ESCC). In this single-center cohort study, our aims include:

  1. evaluate the therapeutic efficacy and survival benefits on patients with locally advanced resectable ESCC (cT3-4aN0-1M0);
  2. evaluate the value of genomic indicators in predicting therapeutic responses and prognosis;
  3. evaluate the value of transcriptomic indicators in predicting therapeutic responses and prognosis;
  4. evaluate the value of microbial and metabolite indicators in predicting therapeutic responses and prognosis. Whole exome sequencing, RNA sequencing, 16S rRNA sequencing and Liquid Chromatography with tandem mass spectrometry (LC-MS-MS) of samples of responders and non-responders to neoadjuvant chemoimmunotherapy before and after treatment are performed to explore the mechanisms of drug resistance and identification of predictive and prognosis biomarkers, providing guidance to clinical decisions.
Being tested
neoadjuvant anti-PD-1 plus chemotherapy
Keywords
Esophageal Squamous Cell Carcinoma, Neoadjuvant Chemoimmunotherapy
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.

  • neoadjuvant anti-PD-1 plus chemotherapyDrug

    Patients will be given preoperative treatment as below once recruited:

    1. Chemotherapy is delivered and composed of two cycles of Nab-paclitaxel 135mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 3 weeks;
    2. PD-1 antibody is delivered 200 mg (iv, in 30 minutes) every 3 weeks;
    3. After neoadjuvant therapy of 3-4 cycles, esophagectomy is performed. We advise starting 4 cycles of identical chemoimmunotherapy in 6w after surgery.
Study groups in NCT05740995
Study groupRoleWhat they receive
Neoadjuvant Anti-PD-1 Plus Chemotherapy GroupPatients with locally advanced resectable ESCC (cT3-4aN0-1M0) who receive neoadjuvant anti-PD-1 plus chemotherapy and donate biological samples
Receives: Drug: neoadjuvant anti-PD-1 plus chemotherapy

What is being measured

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

  1. Major pathological regression (MPR) rate

    The resected specimen following neo-adjuvant treatment are assessed by using standardised work up of the resection specimen in the pathology department and standardised histological criteria for tumour regression grading. MPR was defined as ≤10% residual viable tumor.

    Measured: Up to the date of pathological reports obtained since the date of enrollment, up to 6 months

Secondary outcomes (5)

  1. Pathological response rate(pCR)

    The resected specimen following neo-adjuvant treatment are assessed by using standardised work up of the resection specimen in the pathology department and standardised histological criteria for tumour regression grading. PCR was defined as no evidence of vital residual tumor cells.

    Measured: Up to the date of pathological reports obtained since the date of enrollment, up to 6 months

  2. objective response rate (ORR)

    ORR is evaluated by chest, abdominal \& pelvic CT/MRI based on RESIST 1.1. Evaluation will be conducted every 6 weeks during neoadjuvant therapy and every 6 months after surgery.

    Measured: 36 months after the last subject participating in

  3. overall survival (OS)

    OS is defined as time interval from recruitment to all-caused death or censoring.

    Measured: 36 months after the last subject participating in

  4. Progression-free survival(PFS)

    Disease recurrence is defined as locoregional (esophageal bed or anastomotic or regional lymph nodes) or metastatic (supraclavicular lymph nodes or distant organs).

    Measured: 36 months after the last subject participating in

  5. The correlation between detection of genomic, immune, microbial and metabolite features and the rate of therapeutic responses.

    The detection of genomic, immune, microbial and metabolite features from biological samples before and after neoadjuvant chemoimmunotherapy is performed to analyze the correlation to treatment vulnerability.

    Measured: 36 months after the last subject participating in

Timeline

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

  1. First posted23 Feb 2023
  2. Study start1 Dec 2020
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05740995
Sponsor's protocol ID
B2021-129
Status last verified
Mar 2023
First submitted
14 Feb 2023
Last updated
21 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The IPD will not be shared with other researchers in order to protect patients' privacy.

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Squamous Cell Carcinoma and Neoadjuvant Chemoimmunotherapy, run by Shanghai Zhongshan 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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 21 Mar 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Jie Gu, MD (+86 13611972978, gu.jie3@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathological regression (MPR) rate (time frame: Up to the date of pathological reports obtained since the date of enrollment, up to 6 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 NCT05740995.

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 Mar 2023.

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