Clinical Control Study of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Esophageal cancer is still a serious threat to human life and health. China in particular. Relapse and metastasis are important causes of treatment failure. Immunotherapy is a new treatment method, which can be used in combination with chemotherapy to improve the therapeutic effect. However, the role of immunotherapy combined with chemoradiotherapy in concurrent chemoradiotherapy of recurrent esophageal cancer has not been clearly studied. Our team will study it in detail.

The purpose of this study was to compare and analyze the effect of Camrelizumab in concurrent chemoradiotherapy of locally recurrent esophageal cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Camrelizumab Combined With CRT for Treatment of Patients With Local Recurrence of Esophageal Cancer

NCT04390945

Esophageal Cancer

UNKNOWN PHASE2

Definitive (Chemo)Radiotherapy for Patients With Esophageal Cancer - 3JECROG R-01

NCT03298204

Esophagus Cancer Chemoradiation Chemotherapy Effect +1 more

COMPLETED

Concurrent Chemoradiotherapy for Stage IVB Esophageal Squamous Cell Carcinoma（EC-CRT-003）

NCT05512520

Metastatic Esophageal Squamous Cell Carcinoma

RECRUITING PHASE2

Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.

NCT06020885

Esophageal Squamous Cell Carcinoma

ACTIVE_NOT_RECRUITING PHASE1

Minimally Residual of Esophageal Cancer 001

NCT05952661

Esophageal Carcinoma Minimal Residual Disease

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, patients with local recurrence of esophageal carcinoma without distant metastasis were randomly divided into experimental group and control group by Block randomization. In the experimental group, patients with local recurrence were treated with Camrelizumab combined with concurrent chemoradiotherapy. Followed up for 3 years to observe the objective remission rate and disease-free survival. In the control group, patients with local recurrence were treated with placebo combined with concurrent chemoradiotherapy. Followed up for 3 years to observe the objective remission rate and disease-free survival.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Malignant Neoplasm, Local Recurrence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PD-1 and Concurrent chemoradiotherapy

Camrelizumab: 200mg,d1,15,29,43,57,I.V oxaliplatin：65mg/m2，d1，8，22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

Group Type ACTIVE_COMPARATOR

Procedural death 1

Intervention Type DRUG

200mg,d1,15,29,43,57,I.V

Capecitabine

Intervention Type DRUG

Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total.

Radiotherapy

Intervention Type RADIATION

radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

placebo and Concurrent chemoradiotherapy

placebo: 200mg,d1,15,29,43,57,I.V oxaliplatin：65mg/m2，d1，8，22, 29 capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

Group Type PLACEBO_COMPARATOR

Capecitabine

Intervention Type DRUG

Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total.

Radiotherapy

Intervention Type RADIATION

radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

Placebo

Intervention Type DRUG

placebo: 200mg,d1,15,29,43,57,I.V

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Procedural death 1

200mg,d1,15,29,43,57,I.V

Intervention Type DRUG

Capecitabine

Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total.

Intervention Type DRUG

Radiotherapy

radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

Intervention Type RADIATION

Placebo

placebo: 200mg,d1,15,29,43,57,I.V

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Camrelizumab Aibin Radiation Therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1.Age 18-75 years old, both men and women; 2. Histologically confirmed as esophageal squamous cell carcinoma; 3. Postoperative local recurrence of esophageal cancer (stage II-IVA); 4. According to the evaluation criteria of RECIST 1.1, at least one measurable lesion; 5. ECOG: 0 ～ 1; 6. Expected survival time ≥ 12 weeks; 7. The function of main organs is normal, that is, it meets the following standards: Blood routine examination:a. HB≥90g / L; b.ANC≥1.5 × 109 / L; c.PLT≥80 × 109 / L;3.Biochemical inspection:a.ALB ≥ 30g / L; b. ALT and AST ≤ 2.5ULN; c. TBIL ≤ 1.5ULN; 8. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days before the study enrollment , and must be a non-lactating patient; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 9. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Exclusion Criteria

1. Does not meet the above selection criteria;
2. Patients with distant metastases;
3. Those who are allergic to or metabolic disorders of capecitabine and Camrelizumab;
4. The patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis , Hyperthyroidism; The patient has vitiligo; Asthma has been completely relieved in childhood and can be included without any intervention after adulthood; Patients with asthma requiring medical intervention with bronchodilators cannot be included);
5. The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose\> 10mg / day prednisone or other therapeutic hormones), and is still using it within 2 weeks before enrollment; 6. Contraindications to radiotherapy;

7\. Severe infections that are active or uncontrolled; 8. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA≥104 copies / ml or 2000IU / ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the analytical method; 9. Patients whose imaging has shown that the tumor has invaded the important blood vessels or the investigator judges that the tumor is likely to invade the important blood vessels and cause fatal hemorrhage during the follow-up study; 10. Pregnant or lactating women; 11. Patients with other malignant tumors within 5 years (except basal cell carcinoma of the skin and cervical carcinoma in situ); 12. Patients with a history of psychotropic substance abuse who are unable to quit or have mental disorders; 13. Patients who have participated in clinical trials of other drugs within four weeks; 14. According to the judgment of the investigator, there are patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 15. The investigator considers it unsuitable for inclusion.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No