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Esophageal CancerPhase 2NCT06304350

Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Combination of pembrolizumab and platinum containing dual drugs in people with Esophageal Cancer, run by Tongji University 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

This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Combination of pembrolizumab and platinum containing dual drugs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
17 Feb 2024to 31 Dec 2026
Phase
Phase 2
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

Who may be able to join

  • Baseline stage resectable cII/III esophageal squamous cell carcinoma (8th UICC TNM stage);
  • Failure to receive anti-tumor treatment for esophageal squamous cell carcinoma;
  • Age range from 18 to 75 years old;
  • There are no surgical contraindications in the preoperative evaluation of various organ functions;
  • The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for participating in the study: hemoglobin ≥ 9.0g/L; White blood cell count 4.0-10 × 109/L; Neutrophil absolute value (ANC) ≥ 1.5 × 109/L; Platelet count ≥ 100 × 109/L; Total bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST ≤ 2.5 times the upper limit of normal values; The international standardized ratio of prothrombin time is ≤ 1.5 times the upper limit of normal values, and some prothrombin time is within the normal range; Creatinine ≤ 1.5 times the upper limit of normal value;
  • Patients who have not undergone chemotherapy, radiation therapy, or hormone therapy for malignant tumors, have no history of other malignant tumors, and do not include prostate cancer patients who have received hormone therapy and have obtained DFS for more than 5 years;
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  • Expected to achieve R0 resection;
  • Physical state ECOG 0-1;
  • The subjects must understand and sign the informed consent form

Who cannot join

  • Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.);
  • Not suitable for surgery or with surgical contraindications;
  • Have a history of other anti PD-L1/PD-1 treatments;
  • Individuals with immunodeficiency or long-term systemic steroid therapy, or those who have received any immunosuppressive therapy within 7 days prior to receiving the study drug;
  • Individuals with active autoimmune diseases requiring systemic treatment within 2 years;
  • Patients with poor control of heart disease
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  • Pregnant or lactating female patients;
  • For patients with drug allergies in the protocol.
  • Exit criteria：
  • Withdrawal cases refer to subjects who have stopped continuing treatment in clinical research due to various reasons. Subjects who experience the following situations will withdraw from the investigational treatment:
  • The main indicators are missing, and more than half of the items that can be filled in CRF are missing;
  • The surgical procedure violates the plan;
  • Cases that are excluded due to adverse reactions are not evaluated for efficacy, but side effects should be included in the statistics;
  • According to the researcher's opinion, continuing to participate in the study will be harmful to their health;
  • Patients who fail to undergo non-surgical treatment due to various reasons, including malignant tumor progression, underlying disease progression, patient or their trustee requesting withdrawal, will be reported together;
  • Missing subjects. All subjects who withdrew from the study should record their reasons for withdrawal in the CRF and their medical records. According to the ITT principle, all withdrawn cases should undergo survival analysis and toxicity evaluation for the corresponding group.

Trial locations and contacts

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

Jiang Fan, MD contact

15901013210

fan_jiang@tongji.edu.cn

Fu Yang, DM contact

18101839885

China1 site, 1 recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

    Jiang Fan, MD, 02163240090, fan_jiang@tongji.edu.cn

    Jiang Fan, MD

    Recruiting

Other trials in China

About this study

Official title: A Single Arm, Single Center, Phase II Clinical Study of Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma

This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study

Read the detailed description

This study is a prospective, single center, open label, single arm Phase II clinical study. Patients with locally resectable advanced esophageal squamous cell carcinoma were selected for inclusion in the study, who received a 2-course neoadjuvant treatment with pembrolizumab combined with platinum containing dual drugs. After evaluation, surgery was performed. The efficacy and safety of pembrolizumab combined with chemotherapy neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma were observed, with pCR and MPR as the main research endpoints.

Being tested
Combination of pembrolizumab and platinum containing dual drugs
Keywords
esophageal cancer；, Pembrolizumab；, Neoadjuvant therapy
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • Combination of pembrolizumab and platinum containing dual drugsDrug

    After 2 courses of treatment with a combination of pembrolizumab and platinum containing dual drugs (albumin paclitaxel+carboplatin), surgery was performed and pembrolizumab immunomaintenance therapy continued after surgery

Study groups in NCT06304350
Study groupRoleWhat they receive
Combination of pembrolizumab and platinum containing dual drugsExperimentalAfter 2 courses of treatment with pembrolizumab combined with platinum containing dual drugs (albumin paclitaxel+carboplatin), surgery was performed, and postoperative pembrolizumab immunomaintenance therapy continued
Receives: Drug: Combination of pembrolizumab and platinum containing dual drugs

What is being measured

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

  1. Pathological complete remission (pCR)

    Defined as the absence of any residual esophageal squamous cell carcinoma cells, including the primary lesion and lymph nodes

    Measured: in two weeks after the surgical resection

Secondary outcomes (5)

  1. Major pathological remission (MPR)

    The primary pathological response (MPR) is defined as residual survival tumor during surgery ≤ 10%.

    Measured: in two weeks after the surgical resection

  2. R0 resection rate

    Measured: in two weeks after the surgical resection

  3. Progression free survival (PFS)

    Measured: receiving therapy，up to approximately 2years.

  4. Total survival time (OS)

    Measured: The time from the patient's randomization receiving therapy to death from any cause，up to approximately 2years

  5. Safety (incidence of adverse drug reactions)

    Measured: Randomly group patients to receive treatment for up to two years

Timeline

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

  1. First posted12 Mar 2024
  2. Study start17 Feb 2024
  3. Primary completion25 Feb 2026 (estimated)
  4. Study completion31 Dec 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
NCT06304350
Sponsor's protocol ID
SGHDOT-24-20
Status last verified
Mar 2024
First submitted
21 Feb 2024
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
Yes
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 Combination of pembrolizumab and platinum containing dual drugs in people with Esophageal Cancer, run by Tongji University 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 16 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 13 Mar 2024. 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?

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 Jiang Fan, MD (15901013210, fan_jiang@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete remission (pCR) (time frame: in two weeks after the surgical resection). 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 NCT06304350.

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 13 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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