A preliminary study of 68Ga Fapi PET / CT imaging in the early efficacy evaluation of chemotherapy combined with immunotherapy for gastric cancer

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100052309

Enrollment

Unknown

Registered

2021-10-24

Start date

2021-12-01

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

case series:Nil

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with gastric cancer confirmed by pathological specimens and unresectable in advanced or locally advanced stage; 2. Aged >= 18 years, gender is not limited; 3. According to the definition criteria of RECIST1.1, determine whether the patient has measurable lesions or non-measurable lesions; 4. ECOG score of 0-2 points, the expected survival time is at least 3 months; 5. Normal liver and kidney function and bone marrow reserve; white blood cells >= 3.0 x10^9/L; absolute neutrophil value (ANC) >= 1.5 x10^9/L; platelet count >= 75 x10^9/L; hemoglobin (Hb) >= 8 g/dL; total bilirubin <= 2 x upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST) <= 3 x ULN, patients with liver metastases <=5 x ULN; serum creatinine <= 1.5x ULN; 6. Complete imaging examinations related to tumor curative effect evaluation within 2 weeks before enrollment, clinical symptoms and condition evaluation within 1 week before enrollment, three routine examinations of blood, urine and feces, fecal OB, blood biochemistry, electrocardiogram, CEA, CA199, and immune-related indicators ; 7. Be able to understand the purpose of the clinical trial, participate voluntarily and sign the informed consent; 8. Good compliance, able to accept doctor follow-up, and voluntarily abide by the treatment plan during the study; 9. Males or females of childbearing potential voluntarily use contraception in the trial.

Exclusion criteria

Exclusion criteria: 1. Male subjects who are pregnant or breastfeeding, or who are expected to conceive or impregnate a spouse during the planned trial; 2. Known psychiatric or substance use disorders that may affect compliance with trial requirements.

Design outcomes

Primary

Measure	Time frame
68Ga-FAPI PET/CT related parameters, PFS, OS;	—

Countries

China

Contacts

Public ContactXiao Xiuying

Renji Hospital, Shanghai Jiaotong University School of Medicine

xiaoxiuying2002@163.com+86 13564579313

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026