Sintilimab Combined With LDRT for Neoadjuvant Treatment of Locally Advanced dMMR/MSI-H Gastric Cancer

NCT06426654 | Not Yet Recruiting Phase 1

• 1 other identifier: WCH242145
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recently, growing evidences have suggested that immunotherapy represents a promising treatment option for the neoadjuvant treatment of locally advanced mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) gastric cancer. In this study, we will explore the efficacy and safety of sintilimab and LDRT in the neoadjuvant treatment for locally advanced dMMR/MSI-H G/GEJ cancer.

Conditions

Gastric Cancer

Keywords

gastric cancer; neoadjuvant therapy; sintilimab; LDRT

Outcome Measures

Primary Outcomes (1)

• pCR rate

  defined as the absence of viable tumor cells assessed by histological evaluation criteria after neoadjuvant therapy

  5 months after the last subject participating in

Secondary Outcomes (4)

• R0 resection rate

  5 months after the last subject participating in

• MPR rate

  5 months after the last subject participating in

• 3-year event-free survival (DFS)

  every 3 month postoperation up to 36 months

• 2-year OS rate

  every 3 month postoperation up to 36 months

Study Arms (1)

sintilimab+LDRT

EXPERIMENTAL

Laparoscopic exploration is required in all patients to detect occult peritoneal metastases. All patients will start with one cycle of neoadjuvant therapy of sintilimab: 200 mg, iv drip, d1, q3w. Then, LDRT will be performed in the target area (including the primary gastric lesion and positive/suspected positive lymph nodes). After radiotherapy, patients will receive another three cycles of sintilimab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with sintilimab for up to 10 cycles.

Drug: sintiliman plus LDRT

Interventions

sintiliman plus LDRT DRUG

All patients will start with one cycle of neoadjuvant therapy of sintilimab: sintilimab 200 mg, iv drip, d1, q3w. LDRT will be performed in the target area. After radiotherapy, patients will receive another three cycles of sintilimab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with sintilimab for up to 10 cycles.

sintilimab+LDRT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years.
• Histologically or cytologically confirmed diagnosis of locally advanced G/GEJ adenocarcinoma (cT2N+M0 or cT3-4aNanyM0) as assessed by exploratory laparoscopic surgery, ultrasonography and/or CT/MRI.
• Resectable G/GEJ cancer, as judged by experienced surgeons.
• dMMR and/or MSI-H.
• \. Eastern Cooperative Oncology Group performance score (ECOG PS) ≤1. 5. Agree to provide blood, feces, and tissue specimens. 6. The expected survival is longer than 6 months. 7. There was no previous antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and other treatments with antitumor effects).
• \. Adequate organ and hematological function. 9. Strict contraception. 10. Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.

You may not qualify if:

• Unable to comply with the research program or procedures.
• Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment.
• Active autoimmune disease or history of refractory autoimmune disease.
• Receiving corticosteroids (\> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding the following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; and short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.
• Active or clinically significant cardiac disease:
• Congestive heart failure \> New York Heart Association (NYHA) class 2;
• Active coronary artery disease;
• Arrhythmias requiring treatment other than β-blockers or digoxin;
• Unstable angina (with angina symptoms at rest), new angina within 3 months before enrollment, or new myocardial infarction within 6 months before enrollment
• Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor was cured and no evidence of disease was found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment.
• Patients with a history of HIV infection or active hepatitis B/C.
• Ongoing \> level 2 infection.
• Symptomatic brain metastasis or meningioma.
• Unhealed wounds, ulcers or fractures.
• Renal failure patients requiring blood or peritoneal dialysis.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Kun Yang, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengfei Zhang, M.D

CONTACT

+86-17828163584; fly_121988@126.com

Ming Liu, M.D.

CONTACT

+86-18980606324; mingliu721@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share