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Esophageal Squamous Cell CarcinomaPhase 2NCT03946969

Sintilimab in Combination With Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer

A Phase 2 study testing Sintilimab and Liposomal Paclitaxel + Cisplatin + S-1 in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

This study aims to investigate the safety and efficacy of sintilimab combined with platinum-based chemotherapy in neoadjuvant treatment of potentially resectable esophageal cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Sintilimab and Liposomal Paclitaxel + Cisplatin + S-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
9 May 2019to 31 Oct 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed esophageal squamous cell carcinoma.
  • The tumor is located in the middle or lower third of the esophagus ( more than 18cm below incisor), potentially resectable and requiring neoadjuvant therapy (T1b-3, Nany, M0 or T4a, N0-1, M0).
  • No prior treatment for this disease.
  • Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
  • Adequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol.
  • Understand and voluntarily sign the informed consent(s).
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  • Patients who are able to complete the treatment and follow-up according to the study plan.
  • Patients who have sufficient tissue samples and agree to provide their tissue samples and blood samples for detailed analysis.
  • Female patients in child bearing period must have evidence of negative pregnancy test and agree to take effective contraceptive measures during the study.

Who cannot join

  • Patients who may develop tracheoesophageal fistula or aortoesophageal fistula.
  • Patients suffering from severe malnutrition or needing tube feeding.
  • Uncured patients with other malignancies within 2 years.
  • Patients who have active autoimmune diseases or patients who are undergoing treatment of autoimmune diseases.
  • Patients who need systemic glucocorticosteroid treatment (more than 10mg prednisone daily or other equivalent drugs) within 7 days before the neoadjuvant therapy or other immunosuppressive drugs.
  • Patients who have immune deficiency.
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  • Patients with active viral or bacterial infection who need systemic treatment within 7 days before the neoadjuvant therapy.
  • Patients with uncontrolled diabetes mellitus.
  • Patients with interstitial pulmonary disease, noninfectious pneumonia, or pulmonary fibrosis.
  • Patients with preexisting symptoms of sensory or motor nerve damage (greater than Grade 1, WHO) .
  • Patients who have received allogeneic organ or stem cell transplants.
  • Patients who are allergic to drugs or related ingredients in this study.
  • Patients who take part in clinical trials of other drugs or biological therapy at present.
  • Patients with any serious or unstable medical condition or mental illness.
  • Patients who are dependent on or addicted to alcohol or drugs.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: Safety and Efficacy of Combination of Sintilimab and Platinum-based Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer: An Open-lable, Single-arm, Exploratory Clinical Study

This study aims to investigate the safety and efficacy of sintilimab combined with platinum-based chemotherapy in neoadjuvant treatment of potentially resectable esophageal cancer.

Read the detailed description

This study was designed as an open-lable, single-arm, exploratory clinical study. Sintilimab in combination with liposomal paclitaxel, cisplatin and S-1 will be given every 3 weeks to our patients for 2 cycles as neoadjuvant therapy. A radical dissection is scheduled within 6 weeks after last neoadjuvant treatment. This study will be devided for 3 phases: safety run-in, efficacy pilot and efficacy confirmation.

Being tested
Sintilimab, Liposomal Paclitaxel + Cisplatin + S-1
Keywords
Neoadjuvant, Esophageal Cancer, PD-1
Medical subject headings
Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms

What participants receive

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

  • SintilimabDrug

    Also called IBI308

    Sintilimab (200mg) will be given intravenously on day 1 in 3-week cycles for two cycles.

  • Liposomal Paclitaxel + Cisplatin + S-1Drug

    Also called PFC

    Liposomal Paclitaxel (135mg/m2), ivd, d1 + Cisplatin (25mg/m2), ivd, d1-3 + S-1 capsule (40mg), po, d1-14, repeated every 3 weeks for two cycles.

Study groups in NCT03946969
Study groupRoleWhat they receive
Sintilimab + Liposomal Paclitaxel + Cisplatin + S-1ExperimentalSintilimab will be administered prior to the chemotherapy in an interval of half an hour.
Receives: Drug: Sintilimab; Drug: Liposomal Paclitaxel + Cisplatin + S-1

What is being measured

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

  1. Safety and feasibility

    Safety is defined as the incidence of Grade 3-4 Treatment-Related Adverse Events (TRAEs) from the day of neoadjuvant therapy to 30 days after surgery or within 90 days after last neoadjuvant treatment. Feasibility of surgery is defined as the incidence of TRAEs causing surgery delay of ≥30 days and/or inoperable patients.

    Measured: 20 months

Secondary outcomes (4)

  1. MPR rate

    Major Pathological Response (MPR) is defined as the presence of 10% or fewer viable cancer cells in the hematoxylin and eosin (H\&E)-stained slides from the resected tumor following neoadjuvant treatment.

    Measured: 20 months

  2. R0 resection rate

    R0 resection is defined as no cancer cells are seen microscopically at the resection margin following surgery.

    Measured: 20 months

  3. Recurrence-Free Survival (RFS)

    Recurrence-Free Survival (RFS) is calculated from surgery to the date of recurrence or death.

    Measured: 5 years

  4. Overall Survival (OS)

    Overall Survival (OS) is calculated from the beginning of neoadjuvant treatment to the date of death from any cause.

    Measured: 5 years

Timeline

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

  1. First posted13 May 2019
  2. Study start9 May 2019
  3. Primary completion9 Nov 2021
  4. Study completion31 Oct 2022 (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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03946969
Sponsor's protocol ID
KEEP-G 03
Status last verified
Jul 2022
First submitted
9 May 2019
Last updated
19 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen X, Xu X, Wang D, Liu J, Sun J, Lu M, Wang R, Hui B, Li X, Zhou C, Wang M, Qiu T, Cui S, Sun N, Li Y, Wang F, Liu C, Shao Y, Luo J, Gu Y. Neoadjuvant sintilimab and chemotherapy in patients with potentially resectable esophageal squamous cell carcinoma (KEEP-G 03): an open-label, single-arm, phase 2 trial. J Immunother Cancer. 2023 Feb;11(2):e005830. doi: 10.1136/jitc-2022-005830.

    PubMed 36759013

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab and Liposomal Paclitaxel + Cisplatin + S-1 in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital with Nanjing Medical 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 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: status not confirmed, as of the sponsor's last update on 19 Jul 2022. 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?

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?

Safety and feasibility (time frame: 20 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 NCT03946969, which also lists 1 linked publication.

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 19 Jul 2022.

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