A Single-arm, Phase II Exploratory Study of Sintilimab in Combination With Chemoradiotherapy in Elderly Patients With Locally Advanced Gastric Cancer

NCT06555471 | Recruiting Phase 2

• 1 other identifier: 123323
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a prospective, single-arm, single-centre, phase II clinical study to explore the efficacy and safety of sintilimab in combination with chemoradiation in subjects over 75 years of age with advanced gastric cancer. Participants will: Take sintilimab (200mg iv q3w d1) combined with chemoradiation. The application of chemotherapy based on investigator's assessment, and if so, S-1 (po d1-d14，q3w； according to body surface area ：\<1.5m\^2 40mg/time；1.5\~1.8m\^2 50mg/time；\>1.8m2 60mg/time) or capecitabine （1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.); Radiotherapy：once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy. Subjects undergo an initial assessment of imaging, physical status, quality of life, and relevant laboratory tests after completion of 3 cycles of sintilimab combination chemotherapy, followed by assessments every 2 months, and after 3 full assessments, assessments every 3 months are initiated.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (4)

• Objective response rate (ORR)

  Proportion of participants in complete and partial remission

  24 months

• Disease control rate (DCR)

  the proportion of patients who achieve tumor relief (PR+CR) and stable disease (SD)

  24 months

• Duration of response (DoR)

  the time from onset of response to progression or death due to any reason, whichever occurs earlier

  24 months

• Progression free survival (PFS)

  the time from initiation of treatment to the occurrence of disease progression or death, whichever occurs earlier.

  24 months

Secondary Outcomes (2)

• Overall survival

  24 months

• Adverse reactions

  24 months

Study Arms (1)

combination therapy sintilimab combined with chemotherapy and radiotherapy

EXPERIMENTAL

Sintilimab (200mg iv q3w d1) combined with chemoradiation. The application of chemotherapy based on investigator's assessment, and if so, S-1 (po d1-d14，q3w； according to body surface area ：\<1.5m\^2 40mg/time；1.5\~1.8m\^2 50mg/time；\>1.8m2 60mg/time) or capecitabine （1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.); Radiotherapy：once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy. Maintenance therapy with sintilimab in combination with S-1 (po d1-d14，q3w； according to body surface area ：\<1.5m\^2 40mg/time；1.5\~1.8m\^2 50mg/time；\>1.8m2 60mg/time) or capecitabine （1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.) up to 2 years.

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

Interventions

Sintilimab DRUG

Sintilimab: 200mg iv q3w d1

combination therapy sintilimab combined with chemotherapy and radiotherapy

S-1 DRUG

po d1-d14，q3w； according to body surface area ：\<1.5m\^2 40mg/time；1.5\~1.8m\^2 50mg/time；\>1.8m2 60mg/time)

combination therapy sintilimab combined with chemotherapy and radiotherapy

Capecitabine DRUG

1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.

combination therapy sintilimab combined with chemotherapy and radiotherapy

Extraperitoneal radiation therapy RADIATION

once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy

combination therapy sintilimab combined with chemotherapy and radiotherapy

Eligibility Criteria

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

You may qualify if:

• Histopathologically confirmed locally advanced (T3-4N+M0) adenocarcinoma of the stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma).
• HER-2 negative.
• Age ≥75 years.
• ECOG PS score of 0-2
• have at least one measurable lesion or assessable lesion according to RECIST v1.1.
• have adequate organ and bone marrow function as defined below:
• Haematology: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; haemoglobin level ≥ 9.0 g/dL.
• Liver function: Serum total bilirubin (TBIL) ≤ 1.5× the upper limit of normal (ULN); for patients with liver metastases or a history/suspicion of Gilbert's syndrome (persistent or recurrent hyperbilirubinemia, primarily unconjugated hyperbilirubinemia without evidence of hemolysis or liver disease), TBIL ≤ 3× ULN; for patients without hepatocellular carcinoma (HCC) and liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× ULN; for patients with HCC or liver metastases, ALT or AST ≤ 5× ULN.
• Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL/min; urine protein \< 2+ on urine test paper.
• Coagulation function: activated partial thromboplastin time (APTT) and international normalised ratio (INR) ≤ 1.5×ULN.
• Cardiac enzyme profile within normal range
• Normal thyroid function, defined as thyrotropin (TSH) within normal range. If baseline TSH is outside the normal range, subjects may also be enrolled if total T3 (or FT3) and FT4 are within the normal range;
• expected survival time ≥ 12 weeks;
• Signed written informed consent and able to comply with protocol-specified visits and related procedures.

You may not qualify if:

• known endoscopic signs of active bleeding from the lesion.
• Near obstruction of the cardia and pylorus affecting feeding and gastric emptying, or impaired swallowing of tablets.
• Diagnosis of HER-2 positive adenocarcinoma of the stomach and gastro-oesophageal junction.
• Previous systemic therapy for advanced or metastatic adenocarcinoma of the stomach and gastro-oesophageal junction.
• Malignant disease other than gastric cancer diagnosed within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ);
• Currently being treated in an interventional clinical study or have been treated with another investigational drug or with an investigational device within 4 weeks prior to the first dose;
• Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs targeting another stimulatory or synergistic inhibitor of T-cell receptors (e.g., CTLA-4, OX-40, CD137);
• active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating medications, glucocorticoids, or immunosuppressive agents) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic therapy;
• are receiving systemic glucocorticoid therapy (excluding topical glucocorticosteroids by nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are permitted;
• known for allogeneic organ transplantation (except corneal transplantation) or allogeneic haematopoietic stem cell transplantation;
• Known allergy (grade 3 or higher) to any monoclonal antibody or component of a chemotherapeutic drug (Tegretol/Capecitabine) preparation;
• has not fully recovered from toxicity and/or complications resulting from any intervention prior to initiation of therapy (i.e., ≤ Grade 1 or at baseline, excluding malaise or alopecia);
• known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
• Untreated active hepatitis B (defined as HBsAg positivity with a detectable HBV-DNA copy number greater than the upper limit of normal in the laboratory of the study centre); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled:
• HBV viral load \<1000 copies/ml (200 IU/ml) prior to the first dose, and subjects should receive anti-HBV therapy throughout the duration of study chemotherapeutic drug treatment to avoid viral reactivation;

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; S 1 (combination); Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Yan Yang

CONTACT

13512517281; yy17281@aliyun.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: August 13, 2024
• First Posted: August 15, 2024
• Study Start: August 6, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

CN (1)