Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Esophagogastric Junction Adenocarcinoma

NCT05505461 | Not Yet Recruiting Phase 2

• 1 other identifier: WCWKZL-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the effect and safety of concurrent PD-1 antibody-based long-term radiotherapy followed by 2 cycles SOX with PD-1 in patients with locally advanced adenocarcinoma of esophagogastric junction.

Conditions

Adenocarcinoma of Esophagogastric Junction

Keywords

PD-1, neoadjuvant therapy, radiotherapy

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Responce (pCR) Rate

  Proportion of patients with AEG who received neoadjuvant theray with radiation plus PD-1 antibody and SOX regimen and postoperative pathological examination shows pathological complete responce

  Up to 6 months

Secondary Outcomes (4)

• R0 Resection Rate

  Up to 6 months

• Progression Free Survival (PFS)

  Up to 3 years

• Adverse Events

  Up to 6 months

• Surgery Morbidity

  30 days and 12-months after surgery

Study Arms (1)

Neoadjuvant therpy

EXPERIMENTAL

Neoadjuvant chemoradiation plus SOX and PD-1 antibody

Drug: neoadjuvant Radiation plus SOX and PD-1 antibody

Interventions

neoadjuvant Radiation plus SOX and PD-1 antibody DRUG

Patients will be given the perioperative treatment as below once recruited: First, neoradiation (5w) will be given: intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas. PD-1 antibody will be started concurrent the radiation for 2 cycles. The neochemotherapy (SOX) and PD-1 antibody will be given for 2 cycles after 1 week since radiation completed ; Patients will rest 2 weeks after the last cycle of neochemotherapy, and evaluation will be performed during this time. And D2 surgery will be performed if resectable. SOX and PD-1 antibody will be given q3w. Adjuvant chemotherapy: We advise starting 4 cycles of SOX regimen in 3-8w after surgery.

Also known as: Neoadjuvant Chemoradiotherapy plus Immunotherapy

Neoadjuvant therpy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of esophagogastric junction, and Her-2 negative.
• Clinically diagnosed stage T3+orN+M0, according to CT/MRI scan.
• No prior anti-tumor treatment, including surgery, chemotherapy, radiotherapy, and targeted therapy.
• Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1.
• At least one evaluable lesion in abdominal CT/MRI according to RESIST 1.1 is required.
• Expected survival ≥6 months.
• Adequate organ function, Hemoglobin ≥90g/L; White blood cells ≥3.0×109/L; neutrophil count ≥1.5×109/L; Platelets ≥100×109/L; Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the ULN; Urine protein \< 2+; if urine protein ≥ 2+, 24-hour urine protein quantification shows that protein must be ≤ 1 g.
• Normal coagulation function, no active bleeding and thrombotic diseases: International Standardized Ratio INR≤1.5×ULN; Partial thromboplastin time APTT≤1.5×ULN; Prothrombin time PT≤1.5ULN;
• Previous use of anti-tumor Chinese medicines, proprietary Chinese medicines, and immunomodulators (such as thymosin, interleukin, etc.) must be ≥ 2 weeks from the start of the study medication;
• Female patients should not be pregnant or breast feeding. Male should contraception.
• Able and willing to give informed consent to participate.
• Those who are expected to have good compliance.

You may not qualify if:

• Existence of other active malignant tumors within 5 years or at the same time.
• Already received chemotherapy, radiation therapy, targeted or immunotherapy.
• Have any active autoimmune disease or history of autoimmune disease.
• Patients with congenital or acquired immunodeficiency.
• Use of immunosuppressive drugs within 14 days before the study start.
• Administer live attenuated vaccines within 4 weeks before the study start.
• Suffering from uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) poorly controlled arrhythmia.
• Patients with past and current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, etc., and severely impaired lung function.
• Suffering from active pulmonary tuberculosis.
• Complicated severe infection within 4 weeks before the the study start, or unexplained fever \>38.5°C during the screening period/before the study start.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• \. Allergic to any drug in this study. 14. Combined with other severe, acute and chronic diseases that may increase the risk of participating.
• Participators who had been recruited by other clinical trial within three months.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

Neoadjuvant Therapy; Immunotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Immunomodulation; Biological Therapy

Study Officials

• Yingjiang Ye, MD，PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liyu Zhu, MD

CONTACT

+8610-66583821; wcwkzlward@163.com

Jing Zhou, MD

CONTACT

+8610-66583820; wcwkzlward@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: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of gastrointestinal surgery

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)