Immunotherapy After Radiotherapy in Elderly ESCC

NCT05791136 | Not Yet Recruiting Phase 2

• 1 other identifier: ZJLSRT-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The incidence and mortality of esophageal squamous cell carcinoma are at the forefront in China.Most part of patients are elderly. Concurrent chemoradiotherapy is the standard treatment for unresectable locally advanced esophageal squamous cell carcinoma. Most elderly patients cannot tolerate concurrent chemotherapy because of complications and other reasons. Immunotherapy has definite efficacy and low toxicity in advanced esophageal squamous cell carcinoma, and the results combined with radiotherapy have also been preliminarily reported. Therefore, it is necessary to further explore the efficacy and safety of radiotherapy combined with immunotherapy in elderly patients with esophageal squamous cell carcinoma.

Conditions

Esophageal Squamous Cell Carcinoma by AJCC V8 Stage

Keywords

Esophageal Squamous Cell Carcinoma; PD-1; Elderly; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  We aim to evaluate the progression-free survival (PFS) of elderly patients with unresectable esophageal squamous cell carcinoma who were unable to accept concurrent chemotherapy and received sequential treatment with Triptolide injection after radiotherapy alone.

  2 years

Secondary Outcomes (4)

• Overall survival (OS)

  2 years

• Objective response rate (ORR)

  2 years

• Duration of response (DOR)

  2 years

• Time to death or distant metastasis (TTDM)

  2 years

Study Arms (1)

Radiotherapy Sequential Toripalimab

EXPERIMENTAL

Radiotherapy:Intensity-modulated radiotherapy (IMRT) Immunotherapy: Toripalimab

Radiation: Radiotherapy; Drug: Toripalimab

Interventions

Radiotherapy RADIATION

95% PGTV56-60Gy/28-30 fractions, 2Gy/1 fractions; 95% PTV50.4-54Gy/28-30 fractions, 1.8Gy/1 fractions; 5 days a week; 6 weeks.

Also known as: Intensity-modulated radiotherapy (IMRT)

Radiotherapy Sequential Toripalimab

Toripalimab DRUG

Toripalimab (200 mg, intravenously infused) will be administered as the maintenance treatment every 3 weeks within 4 weeks after the completion of radiotherapy for 1 years or until progression, intolerable toxicity, or physician/patient decision

Also known as: Immunotherapy

Radiotherapy Sequential Toripalimab

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥75 years old, regardless of gender；
• Esophageal cancer confirmed by histology or cytology；
• Unresectable, unable to tolerate or refuse surgery and concurrent chemoradiotherapy；
• Unable to tolerate chemotherapy；
• There are at least one lesions measurable according to RECIST 1.1；
• Stage II-iva (AJCC 8 TNM classification)
• Endoscopic ultrasonography confirmed that esophageal lesions did not invade adjacent organs (T1-4a).；
• ECOG PS 0-1；
• Forced expiratory volume (FEV) \>0.8 liter；
• Life expectancy of at least 12 weeks；
• Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, biotherapy，etc.
• Has sufficient organ function： (1) Blood routine: ANC≥1.5×109/L; PLT≥50×109/L; HGB≥90 g/L((No blood transfusion and blood products within 14 days, no use of G-CSF and other blood-stimulating factors to correct)) (2) Liver function: TBIL ≤ 1.5 × ULN，ALT、AST ≤2.5 × ULN， (3) Renal function: Cr≤1×ULN or crcl ≥50 ml/min (4) Adequate haemostasis laboratory data prior to randomization: INR or PT ≤1.5×ULN (If the subject was receiving anticoagulant therapy, as long as the PT was within the intended use range of anticoagulant drugs) (5) Myocardial enzymes were within the normal range.
• Patients voluntarily joined this study, signed informed consent and provided diagnosis and treatment data after cancer diagnosis before entering the group, good compliance, and cooperation with follow-up visits;

You may not qualify if:

• Synchronous or metachronous second primary malignancy. Participants with basal cell carcinoma of the skin, or cervical cancer in situ that have undergone potentially curative therapy are not excluded from the study;
• with multifocal primary esophageal cancer;
• The pathological diagnosis was esophageal small cell carcinoma, adenocarcinoma, or mixed carcinoma.
• Esophageal squamous cell carcinoma with active bleeding within 2 months of the primary lesion；
• 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
• The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, glomerulonephritis, thyroiditis (patients with vitiligo or asthma has been completely relieved in childhood, and do not need any intervention during adulthood can be included; patients with type I diabetes with good insulin control can also be included; hypothyroidism caused by autoimmune thyroiditis requiring hormone replacement therapy can also be included)
• Clinically significant cardiac disease or impaired cardiac function, such as: MeanQT interval corrected for heart rate (QTc) ≥470 ms, Congestive heart failure requiring treatment (New York Heart Association \[NYHA\] grade \> 2), left ventricular ejection fraction (LVEF) \<50% as determined by Echocardiography.
• Active infection or fever of unknown origin \> 38.5 ° C during screening or before the first dose (tumor-related fever, as judged by the investigator, was eligible);
• Current pneumonitis or interstitial lung disease or history of pneumonitis or interstitial lung disease.
• Has had congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 104 copies/ml) or hepatitis C (HCR-RNA was higher than the detection limit of the analytical method);
• Previous treatment with another PD-1, PD-L1；
• Known hypersensitivity to macromolecular protein preparations or to any anti-PD-1 antibody component;；
• Immunosuppressive drugs used within 7 days prior to the initial study treatment, excluding local glucocorticoids, or systemic glucocorticoids at physiological doses (i.e., no more than 10 mg/ day of prednisone or equivalent doses of other glucocorticoids); Systemic steroid doses of less than 10 mg of prednisone daily or its equivalent are allowed in patients receiving physiologic replacement steroid doses without autoimmune disease.
• if they had undergone major surgery patients must have fully recovered from surgery with no major ongoing safety issues before the experiment begins.
• Currently participating in an interventional clinical research treatment, or has received another investigational drug or used an investigational device within 4 weeks prior to the first administration of the drug.

Sponsors & Collaborators

• The Central Hospital of Lishui City: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Radiotherapy; Radiotherapy, Intensity-Modulated; toripalimab; Immunotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Immunomodulation; Biological Therapy

Study Officials

• Zhifeng Tian, M.D

  Lishui Municipal Central Hospital，Zhejiang，China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhifeng Tian, M.D

CONTACT

0578-2285350; tzf419@hotmail.com

Wencai Li, M.D

CONTACT

0578-2285250; liwencai2021@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: April 1, 2023
• Primary Completion: April 30, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share