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Esophageal Squamous Cell CancerPhase 2NCT04804696

Toripalimab with Paclitaxel and Cisplatin As Neoadjuvant Treatment for Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Toripalimab, Paclitaxel and Cisplatin in people with Esophageal Squamous Cell Cancer, run by Peking University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Neoadjuvant chemoradiotherapy or chemotherapy followed by surgery is the standard treatment for local advanced esophageal cancer (EC). It had been demonstrated that patients who achieve pathologic complete response (pCR) after neoadjuvant treatment had better prognosis. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Esophageal Squamous Cell Cancer
What is being tested?
Toripalimab, Paclitaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
10 Feb 2021to 29 Nov 2024
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

  • Age: 18-70 years old, both gender.
  • Histopathologically confirmed esophageal squamous cell carcinoma.
  • No previous chemotherapy, radiotherapy, traditional Chinese medicine and other anti-tumor treatments.
  • Imaging (CT or MR) or ultrasound endoscopy confirmed local advanced resectable lesions ( AJCC 8th edition standard, stage 3N0M0 or T1-4aN+M0).
  • The ECOG performance status score of 0-1.
  • Normal functionof all major organs, that is:
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  • Hemoglobin (Hb) ≥ 100g/L,
  • Neutrophils (ANC) ≥ 1.5×109/L, ③ Platelet count (PLT) ≥100×109/L, ④ Prothrombin time (PT) and partial prothrombin time (PTT) ≤ 1.5×upper limit of normal (ULN). (For the use of a stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin, if the INR is within the expected therapeutic range of anticoagulants, patient could be screened); ⑤ Serum creatinine (Cr) ≤ 1.5 ×ULN, or 24-hour creatinine clearance rate >60mL/min（Cockcroft-Gault）; ⑥ Total blood bilirubin (TB) ≤ 1.5ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; albumin (ALB) ≥ 30g/L.
  • The cardiac function is basically normal, the left ventricular ejection fraction is ≥50%, and the blood pressure is under controlled within 140/90 mmHg before enrollment.
  • Pulmonary function is basically normal, without moderate to severe obstructive and diffuse dysfunction.
  • Be able to provide tissue samples for biomarkers analysis, such as PD-L1 expression.
  • Women of childbearing age must have taken reliable contraceptive measures or undergo a pregnancy test (serum) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception. For men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial period and within 8 weeks after the last trial drug administration;
  • Voluntarily sign an informed consent form (or signed by a legal representative) to prove that they understand the purpose of the research and the operations required by the research and are willing to participate in the research.

Who cannot join

  • Adenocarcinoma, small cell carcinoma, and other non-squamous cell carcinoma types of esophageal cancer.
  • Imaging examinations (CT or MRI) or endoscopic ultrasonography revealed early stage esophageal cancer, including: carcinoma in situ (Tis), lesions only invaded the mucosa layer or the muscularis propria without lymph node metastasis (T1-2N0).
  • Imaging examinations (CT or MRI) revealed unresectable disease including invasion of vertebral body, aorta, and organs (T4b), or with distant metastases such as lungs, liver, bones and other organ metastases (M1) ;
  • Imaging (esophagography, CT or MR) examination within 4 weeks before enrollment revealed esophageal mediastinal fistula or esophagotracheal fistula.
  • Gastrointestinal bleeding such as hematemesis or melena within 4 weeks before the first dose of treatment.
  • Allergic to PD-1 antibodies, paclitaxel, or cisplatin.
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  • Receiving previous anti-tumor treatments such as chemotherapy, radiotherapy, molecular targeted therapy, or Chinese medicine treatment within 4 weeks before enrollment.
  • Receiving corticosteroids (>10 mg prednisone or equivalent dose per day) or other immunosuppressive therapy within 2 weeks before enrollment, except for those who use corticosteroids to prevent allergies, nausea, and vomiting.
  • Received live vaccines within 4 weeks before the first dose of treatment.
  • Receiving major surgery or suffered severe trauma within 4 weeks before the first dose of treatment.
  • Complicated with active autoimmune diseases, or history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but Not limited to these diseases or syndromes). Except: vitiligo, cured childhood asthma/allergic adults without any intervention, autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone, and type I diabetes with a stable dose of insulin.
  • A history of immunodeficiency, including HIV positive, acquired or congenital immunodeficiency diseases, organ transplantation, or bone marrow transplantation.
  • With clinical symptoms of cardiovascular diseases which were not well controlled, including but not limited to: heart failure above NYHA II; unstable angina; myocardial infarction within 1 year; clinically significant supraventricular or ventricular arrhythmia and is still uncontrolled without clinical intervention or clinical intervention;
  • Severe infections (CTC AE> Grade 2) occurred within 4 weeks before the first dose of treatment, such as severe pneumonia, bacteremia, infectious comorbidities that require hospitalization, etc.; baseline chest imaging examinations suggest the presence of active lungs Inflammation; having symptoms and signs of infection or taken oral or intravenous antibiotic treatment within 2 weeks before the first dose of treatment except for prophylactic use of antibiotics.
  • A history of interstitial lung disease and a history of non-infectious pneumonia.
  • With active pulmonary tuberculosis infection identified by medical history or CT examination, or a history of active pulmonary tuberculosis infection within 1 year before enrollment.
  • Active hepatitis B (quantity of HBV DNA ≥100 IU/mL), or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the lower limit of the analytical method) infection.
  • Complicated with chronic nephritis, or urine routine test indicates urine protein ≥ ++, or 24-hour urine protein ≥ 1.0 g.
  • Abnormal blood coagulation function (INR or PT or PTT> 1.5 ULN), potential risk of bleeding, or receiving thrombolysis or anticoagulation therapy;
  • With other malignant tumor diagnosed within 5 years before the first dose of treatment. Exclude malignant tumors with low risk of metastasis and death, such as fully treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.
  • Women who are pregnant or breastfeeding.
  • According to the researcher's judgment, there are other factors that may lead to forced termination. Such as suffering from other serious diseases (including mental illness) requiring combined treatment, significant abnormal laboratory test values, or family or social factors, etc., may affect the safety of subjects or the collection of experimental data.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital / Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Neoadjuvant chemoradiotherapy or chemotherapy followed by surgery is the standard treatment for local advanced esophageal cancer (EC). It had been demonstrated that patients who achieve pathologic complete response (pCR) after neoadjuvant treatment had better prognosis. However, the pCR rate were about only 5-10% in neoadjuvant chemotherapy and 20-40% in neoadjuvant concurrent chemoradiotherapy.

PD-1 antibody based immunotherapy alone as second-line treatment or combined with chemotherapy as first-line treatment had been proved that could prolong overall survival of EC patients. And a recent phase 3 clinical trial CheckMate 577 reported that, as adjuvant treatment, nivolumab could improve disease-free survival in EC and esophageal-gastric junction cancer.

The aim of this study was to evaluate the efficacy and safety of toripalimab, an anti-PD-1 antibody, combined with paclitaxel and cisplatin as neoadjuvant treatment in local advanced esophageal squamous cell carcinoma (ESCC). We hope this combining treatment would increase the pCR rate of neoadjuvant chemotherapy and improve survival of patients, and at the menatime avoid the adverse events of neoadjuvant radiotherapy. This study will provide valuable information for further clinical trials of both Toripalimab and other immune checkpoint inhibition agents in treatment of esophageal cancer.

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.

  • ToripalimabDrug

    Also called JS001, TAB001

    Patients received toripalimab 240 mg I.V. drip on days 1 and 22.

  • PaclitaxelDrug

    Patients received paclitaxel of 175mg/m2 I.V. drip on days 1 and 22.

  • CisplatinDrug

    Patients received cisplatin of 70mg/m2 I.V. drip on days 1 and 22.

Study groups in NCT04804696
Study groupRoleWhat they receive
TPC treatmentExperimentalNeoadjuvant treatment of toripalimab, paclitaxel and cisplatin
Receives: Drug: Toripalimab; Drug: Paclitaxel; Drug: Cisplatin

What is being measured

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

  1. Pathologic complete response rate

    The rate of pathologic complete response rate after neoadjuvant therapy.

    Measured: Three weeks after surgery of last enrolled subject. Estimate up to 2 years

Secondary outcomes (6)

  1. Objective Response Rate

    The percentage of patients having a complete response or a partial response to protocol treatment. Objective response will be measured by RECIST 1.1.

    Measured: One month after 2 cycles' treatment of last enrolled subject. Estimate up to 2 years

  2. R0 resection rate

    The R0 resection rate of esophagectomy

    Measured: Three weeks after surgery of last enrolled subject. Estimate up to 2 years

  3. Major pathologic response rate

    The percentage of subjects with ≤10% survival tumor cells in the resected specimens after neoadjuvant therapy accounted for all subjects who received surgical treatment.

    Measured: Three weeks after surgery of last enrolled subject. Estimate up to 2 years.

  4. Disease-free survival

    The time from enrollment to recurrence of tumor or death.

    Measured: From date of surgery until the date of death from any cause or the date of first documented disease progression whichever came first. Estimate up to three years.

  5. Overall survival

    The length of time from enrollment until the time of death

    Measured: From enrollment to death of patients. Estimate up to 5 years.

  6. Adverse events

    The incidence of adverse events and the incidence of severe adverse events（ grade 3-4) .

    Measured: From enrollment to 60 days after the end protocol treatment

Timeline

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

  1. First posted18 Mar 2021
  2. Study start10 Feb 2021
  3. Primary completion29 Nov 2024
  4. Study completion29 Nov 2024

Why it stopped: Several clinical trials had showed that anti-PD-1 agents combined with chemotherapy as neoadjuvant treatment could increase pCR rate in 2024. In order to protect the interest of patients, this trial was stopted.

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04804696
Sponsor's protocol ID
ESCC003
Status last verified
Feb 2025
First submitted
16 Mar 2021
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
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 Toripalimab, Paclitaxel and Cisplatin in people with Esophageal Squamous Cell Cancer, run by Peking 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 13 inclusion and 22 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: stopped early, as of the sponsor's last update on 21 Feb 2025. 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 was stopped early (reason given: Several clinical trials had showed that anti-PD-1 agents combined with chemotherapy as neoadjuvant treatment could increase pCR rate in 2024. In order to protect the interest of patients, this trial was stopted.). 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?

Pathologic complete response rate (time frame: Three weeks after surgery of last enrolled subject. Estimate up to 2 years). 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 NCT04804696.

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 Feb 2025.

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