AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaNCT06048926

Carrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Unresectable Esophageal Squamous Cell Carcinoma

A study testing Carrelizumab, Paclitaxel injection and Cisplatin in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University 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
Search all trials

Trial summary

This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of carrelizumab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy in the treatment of patients with inoperably advanced esophageal cancer, and… 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?
Carrelizumab, Paclitaxel injection and Cisplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteChina
Study dates
30 Jul 2022to 30 Jul 2028
Phase
Interventional
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

  • Patients voluntarily participate in this study and sign informed consent;
  • Age 18-75 years, including 18 and 75 years old, male or female;
  • Patients with histologically confirmed locally advanced esophageal squamous cell carcinoma with a clinical stage of stage II-IVa that is inoperably resectable (including unresectable, or has contraindications to surgery or refuses surgery) (according to the 8th edition AJCC stage, the pre-treatment clinical stage is: cT1N2-3M0, cT2-4bN0-3M0);
  • the presence of measurable and/or non-measurable lesions that meet the definition of the Efficacy Evaluation Criteria for Solid Tumors (RECIST1.1);
  • Have not received systemic antineoplastic therapy (including but not limited to systemic chemotherapy, molecularly targeted therapy, immunotherapy, biological therapy, topical therapy, and other investigational therapies)
  • ECOG: 0~1 point
Show all 17Show fewer
  • Fresh or archived tumor tissue samples within 6 months (fresh samples preferred) must be provided for biomarker (such as PD-L1) analysis, the sample type is FFPE tumor tissue block or at least 5 unstained, 3-5 μm thick FFPE tumor tissue section, for subjects who cannot provide tissue samples that meet the above requirements, they can discuss with the sponsor to determine whether to enroll;
  • Expected survival≥ 3 months;
  • The function of vital organs meets the following requirements (no blood components and cell growth factors are allowed 2 weeks before starting screening tests):
  • Absolute neutrophil count (ANC) ≥1.5×109/L;
  • platelets≥ 100×109/L;
  • hemoglobin≥ 9g/dL;
  • serum albumin≥ 2.8 g/dL;
  • Total bilirubin ≤ 1.5 × ULN, ALT, AST and/or AKP≤2.5 × ULN;
  • Serum creatinine ≤1.5 × ULN or creatinine clearance ≥ 60 mL/min (calculated according to the Cockcroft-Gault formula, see Annex II);
  • International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5× ULN (can be screened for anticoagulation at a stable dose such as low molecular weight heparin or warfarin and INR within the expected therapeutic range of anticoagulants);
  • Female subjects of childbearing potential should have a urine or serum pregnancy test within 72 hours prior to receiving the first study drug administration and demonstrate a negative testament,and be willing to use an effective method of contraception during the trial period to 3 months after the last dose. For male participants whose partner is a woman of childbearing age, effective methods of contraception should be used during the trial and up to three months after the last dose

Who cannot join

  • history of surgery for esophageal cancer;
  • history of previous fistula due to primary tumor invasion;
  • a higher risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation;
  • participants with poor nutritional status with a BMI of less than 18.5 kg/m2 or a PG-SGA score of ≥9;
  • have undergone major surgery or severe trauma within 4 weeks prior to the first use of the study drug;
  • presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
Show all 23Show fewer
  • Have received or are currently receiving any of the following treatments:
  • Anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted therapy;
  • Have received any investigational drug within 4 weeks prior to the first use of the investigational drug;
  • Participants who require systemic therapy with corticosteroids (> 10 mg prednisone equivalent per day) or other immunosuppressants within 2 weeks prior to the first study drug, except for local inflammation of the esophagus and for the prevention of allergies and nausea and vomiting. In other special circumstances, it is necessary to communicate with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroid replacement and adrenocorticosteroid replacement at a dose > a potent dose of 10 mg/day prednisone is allowed;
  • Those who have received an antitumor vaccine or have received a live vaccine within 4 weeks prior to the first dose of the study drug
  • have any active autoimmune disease or history of autoimmune disease (eg, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary physitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Except vitiligo or patients with asthma/allergies of the same age who have recovered and do not require any intervention in adulthood; Patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;
  • a history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation;
  • Subjects with uncontrolled cardiac clinical symptoms or diseases, such as (1) heart failure with NYHA II and above, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
  • Severe infection (CTC AE> grade 2) within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, infection comorbidities, etc. requiring hospitalization; Baseline chest imaging suggests active lung inflammation, signs and symptoms of infection present in the 2 weeks prior to first study drug use requiring oral or intravenous antibiotic therapy, except for prophylactic antibiotics;
  • history of interstitial lung disease, noninfectious pneumonia, pulmonary fibrosis, or other uncontrolled acute lung disease;
  • Patients with active tuberculosis infection detected by history or CT examination, or patients with a history of active tuberculosis infection within 1 year prior to enrollment, or patients with a history of active tuberculosis infection more than 1 year before that have not been formally treated;
  • Participants had active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower limit of the assay);
  • Laboratory values of sodium, potassium, and calcium greater than grade 1 were abnormal in the first 2 weeks of randomization and could not be improved after treatment;
  • known allergy to macromolecular protein preparations, or to any carrelizul component, or allergy, hypersensitivity or contraindication to paclitaxel or cisplatin or any of the ingredients used in their preparations;
  • Any other malignancy diagnosed prior to the first use of the study drug, except for malignancies with a low risk of metastasis and death (5-year survival >90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ;
  • pregnant or lactating women; participants of childbearing potential who are unwilling or unable to use effective contraception;
  • According to the investigator's judgment, the subject has other factors that may cause him to be forced to terminate the study halfway, such as other serious diseases (including psychiatric diseases) that require combined treatment, recent combination with other serious diseases (such as myocardial infarction, cerebrovascular accident) considering a high risk of recurrence, serious abnormal laboratory test values, family or social factors, which may affect the safety of subjects or the collection of trial data

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

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing

Other trials in China

About this study

Official title: A Randomized, Double-blind, Parallel-controlled, Multicenter Phase III Clinical Study

This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of carrelizumab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy in the treatment of patients with inoperably advanced esophageal cancer, and to explore the relationship between PD-L1 expression and efficacy in tumor tissues. Experimental group: carrelizumab in combination with concurrent chemoradiotherapy PD-1: carrelizumab: 200 mg/3W Chemotherapy: Paclitaxel: 50 mg/m2/W Cisplatin: 25mg/m2/W Radiotherapy: 50.4 Gy / 28 f Chemotherapy drugs are used for 5 cycles, and carrelibizumab is used for up to 24 months until PD or is intolerable Control group: placebo-resistant in combination with chemoradiotherapy placebo: 200 mg/3 W Chemotherapy: Paclitaxel: 50 mg/m2/W Cisplatin: 25mg/m2/W Radiotherapy: 50.4 Gy / 28 f Chemotherapy drugs are used for 5 cycles, and carrelibizumab is used for up to 24 months until PD or is intolerable

Read the detailed description

Experimental group: carrelizumab in combination with concurrent chemoradiotherapy PD-1: carrelizumab: 200 mg/3W Chemotherapy: Paclitaxel: 50 mg/m2/W Cisplatin: 25mg/m2/W Radiotherapy: 50.4 Gy / 28 f Chemotherapy drugs are used for 5 cycles, and carrelibizumab is used for up to 24 months until PD or is intolerable Control group: placebo-resistant in combination with chemoradiotherapy placebo: 200 mg/3 W Chemotherapy: Paclitaxel: 50 mg/m2/W Cisplatin: 25mg/m2/W Radiotherapy: 50.4 Gy / 28 f Chemotherapy drugs are used for 5 cycles, and carrelibizumab is used for up to 24 months until PD or is intolerable

Being tested
Carrelizumab, Paclitaxel injection, Cisplatin, Concurrent chemoradiotherapy
Keywords
Carrelizumab, Concurrent chemoradiotherapy, Esophageal Squamous Cell Carcinoma
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.

  • CarrelizumabDrug

    Also called Erica

    200 mg/time, iv, Q3W

  • Paclitaxel injectionDrug

    Also called chemotherapy

    50mg/m2,iv, D1, 8, 15, 22, 29, once a week, a total of 5 times

  • CisplatinDrug

    Also called chemotherapy

    25mg/m2，iv， D1、8、15、22、29，once a week, a total of 5 times

  • Concurrent chemoradiotherapyRadiation

    Also called Radiotherapy

    Radiotherapy was given simultaneously at the time of the first dose, and the total dose of radiotherapy was 50.4 Gy, which was completed in 28 divided doses of 1.8 Gy each time, 5 times a week.

Study groups in NCT06048926
Study groupRoleWhat they receive
Experimental group: carrelizumab in combination with concurrent chemoradiotherapyExperimentalStudy drugs were administered intravenously on the first day of each cycle. Administered sequentially: carrelizumab, 200mg/time, paclitaxel, 50mg/m2, cisplatin, 25mg/m2, chemotherapy once a week, a total of 5 doses, carrelizumab every three weeks until PD or intolerable, up to 2 years, simultaneous radiotherapy at the first dose, the total dose of radiotherapy is 50.4Gy, completed in 28 divided doses, 1.8Gy each time, 5 times a week.
Receives: Drug: Carrelizumab; Drug: Paclitaxel injection; Drug: Cisplatin; Radiation: Concurrent chemoradiotherapy
Control group: placebo-resistant in combination with chemoradiotherapyPlacebo comparatorPlacebo: 200 mg intravenously given with Q3W until PD or intolerable, carrelizumab/placebo for up to 2 years. Paclitaxel: 50mg/m2, iv, D1, 8, 15, 22, 29, once a week, a total of 5 times. cisplatin: 25mg/m2,iv, D1, 8, 15, 22, 29, once a week, a total of 5 doses. Radiotherapy: total dose of 50.4 Gy, completed in 28 divided doses of 1.8 Gy each time, 5 times a week.
Receives: Drug: Paclitaxel injection; Drug: Cisplatin; Radiation: Concurrent chemoradiotherapy

What is being measured

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

  1. PFS evaluated by IRC

    IRC stands for Independent Review Committee Assessment，Progression-free disease as assessed by an independent review committee Progression-free survival refers to the time from randomization to the first occurrence of disease progression or death from any cause

    Measured: up to 2 years

Secondary outcomes (3)

  1. OS Overall Survival

    Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.

    Measured: up to 2 years

  2. ORR

    Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

    Measured: through study completion, an average of 18 month

  3. Progression-free survival evaluated by Researchers

    The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.

    Measured: up to 2 years

Timeline

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

  1. First posted21 Sep 2023
  2. Study start30 Jul 2022
  3. Primary completion30 Jul 2025 (estimated)
  4. Study completion30 Jul 2028 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06048926
Sponsor's protocol ID
GXL-004
Status last verified
Sep 2023
First submitted
16 Mar 2023
Last updated
21 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Carrelizumab, Paclitaxel injection and Cisplatin 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 17 inclusion and 23 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 21 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

PFS evaluated by IRC (time frame: 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 NCT06048926.

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 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in