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

Sponsor

The First Affiliated Hospital of Henan University of Science and Technology (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04404491

Collaborator

(none)

240

Enrollment

Arms

36.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Malignant Neoplasm, Local Recurrence	Drug: Procedural death 1 Drug: Capecitabine Radiation: Radiotherapy Drug: Placebo	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Third Phase of Immunotherapy and Concurrent Chemoradiotherapy in Patients With Esophageal Cancer Recurrence Was Compared With the Clinical Comparison

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Procedural death 1 200mg,d1,15,29,43,57,I.V Other Names: Camrelizumab Drug: Capecitabine Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. Other Names: Aibin Radiation: Radiotherapy radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w. Other Names: Radiation Therapy
Placebo Comparator: 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.	Drug: Capecitabine Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total. Other Names: Aibin Radiation: Radiotherapy radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w. Other Names: Radiation Therapy Drug: Placebo placebo: 200mg,d1,15,29,43,57,I.V

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Procedural death 1

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

Other Names:

Camrelizumab

Drug: Capecitabine

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

Other Names:

Aibin

Radiation: Radiotherapy

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

Other Names:

Radiation Therapy

Placebo Comparator: 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.

Drug: Capecitabine

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

Other Names:

Aibin

Radiation: Radiotherapy

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

Other Names:

Radiation Therapy

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Grade 3/4 acute toxicities [90 days]
rade 3/4 acute toxicities occurred during or within 90 days after CRT
PFS [1 year]
Progression Free Survival After completion of the CRT

Secondary Outcome Measures

ORR [16 weeks]
overall remission rate
OS Qol [1 year]
overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Does not meet the above selection criteria;
Patients with distant metastases;
Those who are allergic to or metabolic disorders of capecitabine and Camrelizumab;
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);
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;
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.