Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM

NCT06341595 | Recruiting Phase 2

• 1 other identifier: 123322
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a prospective, single arm, single center, phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis, exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy. Patients will receive sintilimab Injection (200mg iv q3w d1) combined with concurrent radiotherapy and chemotherapy. The chemotherapy regimen will use oxaliplatin 130mg/m2+S-1 40mg/m2 bid d1-14. Radiotherapy is performed using intraperitoneal radiation therapy, once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy (60-66 Gy for lymph node lesions). Radiation therapy starts from the second cycle of Sintilimab Injection combined with chemotherapy. The subjects underwent imaging evaluation after completing 4 cycles of combination chemotherapy and radiation therapy with Sintilimab Injection. Evaluated as a surgical subject (surgical conditions: imaging evaluation of enlarged lymph nodes adjacent to the abdominal aorta with PR or no significant activity), radical surgery will be performed within 4 weeks after the last study drug treatment. After surgery, the researcher will determine the necessity of adjuvant treatment and develop an adjuvant treatment plan based on the subject's condition. Subjects evaluated as inoperable will have their best follow-up treatment plan determined by the researcher.

Conditions

Gastric Cancer; Gastric Cancer Metastatic to Regional Lymph Nodes

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival (RFS)

  Recurrence free survival of patients undergoing surgery after Sintilimab Injection combined with concurrent chemoradiotherapy

  24 months

Secondary Outcomes (5)

• R0 resection rate

  12 months

• Objective response rate (ORR)

  24 months

• Major pathological response rate (MPR)

  12 months

• Overall survival (OS)

  24 months

• Adverse reactions

  24 months

Study Arms (1)

combination therapy

EXPERIMENTAL

sintilimab combined with chemotherapy and radiotherapy

Drug: Sintilimab; Radiation: Extraperitoneal radiation therapy; Drug: Oxaliplatin; Drug: S-1

Interventions

Sintilimab DRUG

Sintilimab: 200mg iv q3w d1, 4-6 cycles

combination therapy

Extraperitoneal radiation therapy RADIATION

Radiotherapy using extraperitoneal radiation therapy, once a day, 5 times a week, 1.8-2 Gy/f, a total of 45-50.4 Gy (lymph node lesion radiation dose of 60-66 Gy)

combination therapy

Oxaliplatin DRUG

oxaliplatin: 130mg/m\^2, D1, Q3W, 4-6 cycles

combination therapy

S-1 DRUG

S-1: 40mg/m\^2, bid, d1-14, 4-6 cycles

combination therapy

Eligibility Criteria

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

You may qualify if:

• Able to provide informed consent and willing to sign an approved consent form;
• age ≥ 18 years old and ≤ 75 years old, male and female;
• Has histologically confirmed diagnosis of gastric or GEJ adenocarcinoma;
• patients with advanced gastric cancer who have para aortic lymph node metastasis at the initial treatment and whose primary tumor site can be treated with D2 radical operation;
• peritoneal exploration to exclude peritoneal metastasis, liver metastasis and other metastasis;
• CT or MRI, PET-CT and other examinations suggest that there is only one unresectable factor, namely, para aortic lymph node metastasis;
• has not receive previous anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.);
• Has at least one measurable lesion as defined by RECIST 1.1 as determined by investigator assessment.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• expected survival time \>3 months;
• sufficient organ function, the subject needs to meet the following laboratory indicators:
• The absolute neutrophil count (ANC) ≥ 1.5x109/l without granulocyte colony stimulating factor in the past 14 days.
• Platelets ≥ 100 without blood transfusion in recent 14 days × 109/l.
• Hemoglobin \>9g/dl without blood transfusion or use of erythropoietin in recent 14 days;
• Total bilirubin ≤ 1.5 × Upper limit of normal value (ULN);

You may not qualify if:

• HER-2 positive status
• peritoneal or other organ metastasis;
• endoscopy shows signs of active bleeding, and history of gastrointestinal perforation and /or fistula within 6 months before enrollment.;
• other malignant diseases other than gastric cancer diagnosed within 5 years before the first administration (excluding skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or carcinoma in situ after radical resection);
• Is currently participating in and receiving study therapy , or having been treated with another research drug or with an investigational medical devices within 4 weeks before the first administration;
• Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD L2 , anti-CD137,anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137);
• have received systemic treatment with Chinese patent drugs with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control ascites) within 2 weeks before the first administration;
• active autoimmune disease requiring systemic treatment (such as the use of disease modifying drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
• being treated with systemic glucocorticoids (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study;
• Note: physiological doses of glucocorticoids (≤ 10 mg/ day of prednisone or equivalent) are allowed;
• Known history of allogeneic organ (except corneal transplantation) or allogeneic hemopoietic stem cell transplantation;
• Known allergy or hypersensitivity to the investigational drugs Sintilimab, Oxaliplatin, S-1 or excipients;
• there are many factors that affect oral drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, cardiac and pyloric obstruction affecting eating and gastric emptying);
• have not fully recovered from the toxicity and / or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or reaching baseline, excluding fatigue or hair loss);
• Human Immunodeficiency Virus (HIV) infection (HIV antibody positive) (i.e. HIV 1/2 antibody positive);

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab; Oxaliplatin; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Yan Yang

CONTACT

13512517281; yy17281@aliyun.com

Dongdong Gu

CONTACT

13815440993; 654034729@qq.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: November 14, 2023
• First Posted: April 2, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-01

Locations

CN (1)