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Esophageal Squamous Cell CarcinomaPhase 2NCT05302011

Neoadjuvant Pembrolizumab Plus Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Pembrolizumab, Carboplatin or Cisplatin and Docetaxel in people with Esophageal Squamous Cell Carcinoma, run by Peking Union Medical College Hospital at 1 site 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

This is a study to evaluate the efficacy and safety of neoadjuvant pembrolizumab plus chemotherapy in resectable locally advanced esophageal squamous cell carcinoma patients Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Pembrolizumab, Carboplatin or Cisplatin and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
1 Jun 2020to 30 Jun 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven squamous cell carcinoma of the esophagus.
  • Surgical resectable (T3 or T4b, N0 or N+, M0), as determined by Endoscopic Ultra Sound (EUS),Positron Emission Tomography/Computed Tomography (PET/CT), Esophageal MRI and enhanced CT scan of neck, thorax and abdomen.
  • Tumor length longitudinal ≤ 10 cm; if larger than 10 cm, inclusion should be discussed with the principal investigator.
  • 18≤Age.
  • Tumor does not involve gastro-esophageal junction.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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  • Adequate hematological, renal and hepatic functions defined as:
  • neutrophiles ≥ 1.5 x 109/L platelets ≥ 100 x 109/L alanine transaminase≤2 x upper normal limit hemoglobin ≥ 5.6 mmol total bilirubin ≤ 1.5 x upper normal limit creatinine clearance (Cockcroft) ≥60 ml/min
  • Written, voluntary informed consent

Who cannot join

  • Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer.
  • T1, T2 tumors or in situ carcinoma.
  • metastatic oesophageal cancer.
  • Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.
  • Previous chemotherapy, radiotherapy, and/or treatment with checkpoint inhibitors.
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) precluding major surgery.
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  • Pulmonary fibrosis and/or severely impaired lung function precluding major surgery.
  • Pre-existing motor or sensory neurotoxicity greater than World Health Organization (WHO) grade 1.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10 mg/day prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Dementia or altered mental status that would prohibit the understanding and giving of informed consent
  • Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine.
  • Has an active infection requiring systemic therapy which has not resolved 3 days (simple infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior to the first dose of trial treatment.
  • Has a diagnosis of acute or chronic hepatitis B, hepatitis C, known immunodeficiency or human immunodeficiency virus (HIV).
  • Patients with prior allogeneic stem cell or solid organ transplantation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Prospective, Single-armed Study to Evaluate the Efficacy and Safety of Neoadjuvant Pembrolizumab Plus Chemotherapy in Resectable Locally Advanced Esophageal Squamous Cell Carcinoma Patients

This is a study to evaluate the efficacy and safety of neoadjuvant pembrolizumab plus chemotherapy in resectable locally advanced esophageal squamous cell carcinoma patients

Read the detailed description

The primary objective of the study is to assess the tumor response (by irRECIST) and pathological response of neoadjuvant pembrolizumab plus chemotherapy (carboplatin, paclitaxel).

Secondary objectives are:

To assess completion of neoadjuvant pembrolizumab plus chemotherapy. To assess toxicities of neoadjuvant pembrolizumab plus chemotherapy To assess completion of neoadjuvant pembrolizumab plus chemotherapy. To assess withdrawal rate from surgery. To assess delay rate from surgery. To assess R0 resection rate. To assess post-operative complications. Progression Free Survival.

Being tested
Pembrolizumab, Carboplatin or Cisplatin, Docetaxel
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.

  • PembrolizumabDrug

    Pembrolizumab 200mg i.v. day 1-22-43-64

  • Carboplatin or CisplatinDrug

    Also called chemotherapy

    Carboplatin Area Under the Curve(AUC) = 4-5 i.v. day 1-22-43-64 or Cisplatin 75mg/m2 i.v. day 1-22-43-64

  • DocetaxelDrug

    Also called chemotherapy

    75mg/m2 i.v. day 1-22-43-64

Study groups in NCT05302011
Study groupRoleWhat they receive
Neoadjuvant Pembrolizumab Plus ChemotherapyExperimentalNeoadjuvant Pembrolizumab Plus Chemotherapy
Receives: Drug: Pembrolizumab; Drug: Carboplatin or Cisplatin; Drug: Docetaxel

What is being measured

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

  1. tumor response

    assess the tumor response (by irRECIST) of neoadjuvant pembrolizumab plus chemotherapy

    Measured: up to 12 months

  2. pathological response

    assess the pathological responses (by College of American Pathologists(CAP) classification) of neoadjuvant pembrolizumab plus chemotherapy

    Measured: up to 12 months

Secondary outcomes (8)

  1. Percentage completion of treatment

    Percentage completion of treatment in neoadjuvant pembrolizumab plus chemotherapy

    Measured: up to 3 months

  2. Incidence and severity of toxicity

    Incidence and severity of toxicity defined to CTCAE v4.03 and Radiation Oncology Group (RTOG) criteria

    Measured: up to 12 months

  3. Percentage withdrawal rate from surgery

    Percentage withdrawal rate from surgery due to neoadjuvant related complications

    Measured: up to 3 months

  4. Percentage delay of surgery

    Percentage delay of surgery due to neoadjuvant related complications

    Measured: up to 3 months

  5. R0 resection rate

    R0 resection rate

    Measured: up to 3 months

  6. Incidence and severity of post-operative complications to the Clavien-Dindo classification

    Incidence and severity of post-operative complications to the Clavien-Dindo classification

    Measured: up to 3 months

  7. Disease free survival

    Disease free survival

    Measured: up to 24 months

  8. Overall survival

    Overall survival

    Measured: 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 posted31 Mar 2022
  2. Study start1 Jun 2020
  3. Primary completion30 Mar 2023
  4. Study completion30 Jun 2023

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
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05302011
Sponsor's protocol ID
Keypoint-1
Status last verified
Oct 2023
First submitted
21 Mar 2022
Last updated
10 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Carboplatin or Cisplatin and Docetaxel in people with Esophageal Squamous Cell Carcinoma, run by Peking Union Medical College 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 9 inclusion and 15 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 10 Oct 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?

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?

tumor response (time frame: up to 12 months). The study lists 2 primary outcomes in all. 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 NCT05302011.

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 10 Oct 2023.

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