Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.

October 17, 2023 updated by: Fujian Cancer Hospital

Prospective Single-arm, Exploratory, Multicenter Phase II Clinical Study of Camrelizumab Combined With Chemoradiotherapy in the Treatment of Advanced First-line Esophageal Phosphorous Carcinoma

This is a prospective single-arm exploratory clinical study. The efficacy and safety of camrelizumab combined with chemoradiotherapy and camrelizumab combined with chemotherapy were evaluated in patients with advanced esophageal cancer who had not previously received any systemic antitumor therapy for esophageal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Fuzhou, China
        • Recruiting
        • Fujian Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Sign written informed consent and voluntarily participate in this study;
  2. Patients with esophageal squamous cell carcinoma confirmed by histopathology and/or immunohistochemistry (8th edition 2017) had UICC/AJCC TNM stage IVA or oligometastatic stage IVB;
  3. Survival is expected to exceed 3 months
  4. Age 18-75;
  5. ECOG PS 0-2
  6. Never received any systemic anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, targeted and immunotherapy;
  7. Have at least one measurable lesion
  8. Normal function of major organs, including:

    1. Routine blood test (no blood components, cell growth factors, whitening drugs, platelet raising drugs, and anemia correcting drugs are allowed within 14 days before the first use of study drugs)

      White blood cell count ≥ 3.0×10^9/L

      Neutrophil count ≥ 1.0×10^9/L

      Platelet count ≥ 80×109/L

      Hemoglobin ≥ 80 g/L

    2. Blood biochemical examination:

    Total bilirubin ≤ 1.5×ULN

    ALT ≤2.5×ULN, AST ≤2.5×ULN,

    Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 45mL/min

  9. Subjects have good compliance and cooperate with follow-up

Exclusion Criteria:

  1. The presence of uncontrollable pleural effusion, pericardial effusion or ascites that require repeated drainage;
  2. Poor nutritional status, BMI < 18.5 Kg/m^2; If symptomatic nutritional support was corrected before randomization, enrollment could be considered after evaluation by the principal investigator;
  3. Gastrointestinal bleeding (bleeding volume > 200ml/ day);
  4. Patients with deep ulcers as determined by the investigator;
  5. Previous allergy to monoclonal antibodies, any component of camrelizumab, paclitaxel, cisplatin or other platinum-based drugs;
  6. Has received or is receiving any of the following medical treatment:

    1. any radiation, chemotherapy or other antitumor drugs for the tumor;
    2. Being treated with immunosuppressive agents or systemic hormones for immunosuppression purposes (dose >10mg/ day prednisone or equivalent) within 2 weeks prior to the first use of the study drug; In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at a dose of >10mg/ day or its equivalent are permitted;
    3. Received live attenuated vaccine within 4 weeks before the first administration of the study drug;
    4. Major surgery or severe trauma within 4 weeks before the first use of the study drug;
  7. A history of any active autoimmune disease or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (which may be considered for inclusion after hormone replacement therapy); Patients with complete remission of psoriasis or childhood asthma/allergies who did not require any intervention as adults were considered for inclusion, but patients requiring medical intervention with bronchodilators were not included;
  8. A history of immunodeficiency, including being HIV positive, or suffering from another acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
  9. The presence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to:

    Such as (1) NYHAII grade or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias are not well controlled without clinical intervention or after clinical intervention;

  10. Severe infection (CTCAE > 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications requiring hospitalization; Baseline chest imaging examination indicated active pulmonary inflammation, signs and symptoms of infection within 14 days before the first use of study drugs, or the need for oral or intravenous antibiotic treatment, except for prophylactic antibiotic use;
  11. Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year ago but without regular treatment;
  12. The presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL) and hepatitis C (HCV antibody positive and HCV RNA above the assay limit);
  13. In the judgment of the investigator, there are other factors that may lead to the forced termination of the study, such as the presence of other serious medical conditions (including mental illness) requiring concomitant treatment, alcoholism, substance abuse, family or social factors, and factors that may affect the safety or compliance of the subjects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: drug
  1. camrelizumab 200mg intravenous drip d1q3w
  2. Paclitaxel: 150mg/m2 d1 q3w
  3. Platinum: Cisplatin, carboplatin, nedaplatin and other platinum drugs
  4. Radiotherapy dose: 5040cGy/28f radiotherapy efficacy evaluation after 2-3 cycles of chemotherapy PR/SD received local radiotherapy.
200mg intravenous drip d1q3w
150mg/m2 d1 q3w
Cisplatin, carboplatin, nedaplatin and other platinum drugs
Dose: 5040cGy/28f

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate(ORR)
Time Frame: 3 years
ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival(OS)
Time Frame: 3 years
Defined as the time from the enrollment to death from any cause
3 years
Progression free survival(PFS)
Time Frame: 3 years
It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 13, 2022

First Submitted That Met QC Criteria

November 13, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Advanced immunotherapy CRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.