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Esophageal Squamous Cell CarcinomaPhase 1/2CRISNCT06303583

Neoadjuvant Chemoradiotherapy Followed by Sequential Immunotherapy for Thoracic Esophageal Squamous Cell Carcinoma

A Phase 1/2 study testing paclitaxel, carboplatin and tislelizumab in people with Esophageal Squamous Cell Carcinoma, run by Qiu Guoqin at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
paclitaxel, carboplatin and tislelizumab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Jun 2022to 31 Dec 2026
Phase
Phase 1/2
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

  • Ages 18-75.
  • Histology confirmed thoracic esophageal squamous cell carcinoma.
  • ECOG ps 0 to 1.
  • Resectable or potentially resectable T2-4aN0 or T1-4aN+ patients (AJCC/UICC Clinical Staging of Esophageal squamous cell Carcinoma, 8th edition (cTMN)).
  • Length of esophageal lesions <8cm.
  • There were no surgical contraindications.
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  • Neutrophil count ≥1.5*109/L, platelet count ≥10.0*109/L, hemochrome ≥9g/dL; Serum creatinine ≤1.5 times the upper limit of normal value; Bilirubin ≤1.5 times the upper limit of normal value, AST, ALT, AKP≤2.5 times the upper limit of normal value.
  • BMI acuity 18.5 kg/m2.
  • Informed notification and signed informed consent.

Who cannot join

  • Cervical esophageal cancer (upper part of the lesion in the cervical esophagus). Multifocal esophageal carcinoma, lesion length >8cm.
  • Trachea and aorta were invaded (Annex 5).
  • Hoarseness caused by the tumor.
  • Esophageal fistula.
  • Lymph node metastasis in the neck and periceliac artery (AJCC/UICC 8th edition esophageal/esophagogastric junction region lymph node division 1 and 20).
  • A history of active autoimmune disorders or syndromes requiring treatment with systemic steroids or immunosuppressants (except for vitiligo or cured childhood asthma/allergies who do not require any intervention in adulthood; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone).
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  • She is on hormonal or immunosuppressive therapy.
  • He's had an organ transplant.
  • HIV infection, hepatitis C (hepatitis C antibody positive with HCV-RNA above the detection limit of the assay), chronic active hepatitis B (HBV DNA≥2×103IU/ml or >1×104copies/mL).
  • Active tuberculosis, interstitial pneumonia, active infection, poorly controlled diabetes, symptomatic arrhythmia, symptomatic new dysfunction, myocardial infarction, active peptic ulcer, chronic active enteritis within 6 months; Affected during pregnancy or lactation.
  • Major surgery in the last three months.
  • Severe diabetes mellitus with poor drug control, symptomatic arrhythmia, symptomatic cardiac insufficiency, myocardial infarction within 6 months, chronic active enteritis, chronic nephritis. QTc acuity 470 ms.
  • He had a history of malignancy. Previously received chemotherapy, radiotherapy, targeted therapy, immunotherapy and other antitumor therapies.
  • Patients with allergic or contraindicated taxa.
  • Live vaccine is administered within 30 days before the first dose of immunotherapy.
  • Refusal or inability to sign up for ICF study.
  • The investigator decided that the patient was not suitable to participate.

Trial locations and contacts

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

China1 site

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

The purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer

Read the detailed description

This is a single-arm, phase Ib study. Eligibility criteria include histologically confirmed ESCC and clinical T3-4aN0M0 or T2-4aN+M0 (AJCC/UICC 8). Patients received neoadjuvant radiotherapy (41.4Gy in 23 fractions) with concurrent chemotherapy (paclitaxel, 50 mg/m2, carboplatin area under the curve of 2mg/mL/min, QW*5). Then followed by two cycles of tislelizumab (200mg, Q3W). The primary endpoint was the pathological complete response (pCR) rate and safety.

Being tested
paclitaxel, carboplatin, tislelizumab, radiotherapy
Keywords
Neoadjuvant, chemoradiotherapy, tislelizumab
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.

  • paclitaxelDrug

    paclitaxel, 50 mg/m2, QW*5

  • carboplatinDrug

    area under the curve of2mg/mL/min, QW*5

  • tislelizumabDrug

    200mg Q3W, 2cycles

  • radiotherapyRadiation

    41.4Gy in 23 fractions

Study groups in NCT06303583
Study groupRoleWhat they receive
IOExperimentalchemoradiotherapy sequential tislelizumab
Receives: Drug: paclitaxel; Drug: carboplatin; Drug: tislelizumab; Radiation: radiotherapy

What is being measured

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

  1. Complete pathological response rate

    Measured: 1 year

Secondary outcomes (4)

  1. R0 resection rate

    Measured: 1 year

  2. 2-year Disease-free survival rate

    Measured: 2 years

  3. 2-year overall survival rate

    Measured: 2 years

  4. Safety will be analyzed through the incidence of adverse events, serious adverse events

    Measured: Up to 28 days from last dose

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 start1 Jun 2022
  3. Primary completion31 Aug 2024 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06303583
Sponsor's protocol ID
IRB- 2022-213
Acronym
CRIS
Status last verified
Mar 2024
First submitted
4 Mar 2024
Last updated
12 Mar 2024
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 1/2 study testing paclitaxel, carboplatin and tislelizumab in people with Esophageal Squamous Cell Carcinoma, run by Qiu Guoqin 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 17 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: enrolling by invitation, as of the sponsor's last update on 12 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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?

Complete pathological response rate (time frame: 1 year). 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 NCT06303583.

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 12 Mar 2024.

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