Low-dose Radiotherapy Combined With Chemotherapy and AK112 as Second-line Treatment in Patients With Advanced G/GEJ Cancer

NCT06791148 | Recruiting Phase 2

• 1 other identifier: AK112-IIT-C-M-0003
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the efficacy and safety of the combination of albumin-bound paclitaxel and AK112 with low-dose radiotherapy in patients with gastric adenocarcinoma and gastroesophageal junction adenocarcinoma who have failed first-line standard therapy.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS)

  Refers to the date from the date of admission to the date of the first progression of disease or death of any cause, using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

  up to 24 months

• AE

  Number and percentage of participants with Adverse Events(any grade)

  up to 24 months after enrollment or study close

Secondary Outcomes (3)

• Overall survival (OS)

  up to 3 years

• Duration of Response(DoR)

  up to 12 months

• Disease control rate (DCR)

  up to 12 months

Study Arms (1)

low-dose radiotherapy plus chemo and AK112

EXPERIMENTAL

Radiation therapy for metastatic lesions: Radiation therapy begins within 24 hours before medication administration, with a dose of 2Gy per fraction, administered once every three weeks, for a total of four fractions. Chemo：albumin-bound paclitaxel ，100-120mg/m2,i.v.,d2,d9,q3w； AK112：20mg/kg, i.v., d2, q3w

Radiation: Low-dose radiotherapy; Drug: albumin-bound paclitaxel; Drug: AK112

Interventions

Low-dose radiotherapy RADIATION

2Gy/f，q3w，×4f

low-dose radiotherapy plus chemo and AK112

albumin-bound paclitaxel DRUG

100-120mg/m2,i.v.,d2,d9,q3w

low-dose radiotherapy plus chemo and AK112

AK112 DRUG

20mg/kg, i.v., d2, q3w

low-dose radiotherapy plus chemo and AK112

Eligibility Criteria

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

You may qualify if:

• Sign the informed consent form.
• ≥18 years and ≤75 years .
• Histologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (AJCC 8.0);failed first-line standard treatment.
• PS 0-2.
• Expected survival ≥ 6 months.
• With at least one measurable lesion (RECIST 1.1 criteria) in the subject .
• Within 7 days before starting study treatment, no blood components or growth factors have been used, and Adequate organ function is determined by the following criteria:
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L;Platelets ≥ 90 x 10\^9/L
• ;Hemoglobin ≥ 80 g/L;Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times ULN; Serum creatinine ≤ 1.5 times ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 ml/min; Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN Cardiac enzyme levels within normal range (minor lab abnormalities deemed not clinically significant by the investigator are allowed)
• For women of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days before the first dose of study drug. If the urine test is inconclusive, a blood pregnancy test is required. Postmenopausal women are defined as those who have had no menses for at least 1 year or have undergone surgical sterilization or hysterectomy.
• All participants with fertility potential must use contraception with a failure rate \<1% during treatment and for 120 days after the last dose of study drug (or 180 days after the last chemotherapy dose), regardless of gender.

You may not qualify if:

• Diagnosis of any malignancy other than gastric cancer within 5 years before the first dose (excluding cured basal cell or squamous cell skin cancers and/or carcinoma in situ treated with curative intent).
• Imaging during screening shows tumors encasing major blood vessels or with significant necrosis/cavitation, posing a bleeding risk as determined by the investigator.
• Currently participating in another interventional clinical study or received other investigational drugs or devices within 4 weeks before the first dose.
• Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (e.g., thyroid hormone, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments.
• Receiving systemic corticosteroid therapy (excluding nasal, inhaled, or other topical routes) or any other form of immunosuppressive therapy within 7 days before the first dose of the study.
• Known history of allogeneic organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.
• Known allergy to any drug used in this study.
• Not fully recovered from toxicity and/or complications of any prior interventions before starting treatment (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia).
• Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies).
• Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA levels above the upper limit of normal at the study center).
• Active HCV infection (HCV antibody positive with HCV-RNA levels above the lower limit of detection).
• Received live vaccines within 30 days before the first dose (Day 1, Cycle 1). Note: Inactivated seasonal influenza vaccines administered by injection are allowed within 30 days before the first dose; however, intranasal attenuated live influenza vaccines are not permitted.
• Pregnant or breastfeeding women.
• Presence of any severe or uncontrolled systemic diseases, including:
• Significant and symptomatic ECG abnormalities at rest that are difficult to control, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Radiotherapy; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Jia Wei, MD

CONTACT

0086-025-83304616; jiawei99@nju.edu.cn

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: MD

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 24, 2025
• Study Start: July 10, 2024
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

CN (1)