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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05803746
Other study ID # 2022KT114
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2022
Est. completion date July 15, 2024

Study information

Verified date March 2023
Source Peking University Cancer Hospital & Institute
Contact Zhi Yang
Phone 010-88196196
Email pekyz@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to construct a noninvasive approach using 68Ga- Mirc415 PET/CT to detect the PD-L2 expression of tumor lesion in patients with colorectal cancer, lung cancer and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date July 15, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Aged 18-75, male and female, with ECOG score of 0 or 1; 2. Subjects with head and neck tumors, lung cancer, esophageal cancer, breast cancer, ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, melanoma, bone or soft tissue sarcoma, solid tumors or suspected tumor subjects who intend to undergo pathological tissue biopsy or receive tumor surgical treatment in the near future (within 2 months); 3. The expected survival was more than 26 weeks; 4. Blood routine test, liver and kidney function meet the following standards: blood routine: WBC >= 4.0 x 10^9/L or neutrophil >= 1.5 x 10^9/:, PLT >= 100 x 10^9 / L, Hb >= 90g / L; Pt or APTT <= 1.5 upper limit of normal value; liver and kidney function: total bilirubin <= 1.5 x ULT (upper limit of normal value), ALT / AST <= 2.5 upper limit of normal value or <= 5 x ULT (subject with liver metastasis), ALP <= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP <= 4.5 upper limit of normal value); BUN <= 1.5 x ULT, SCR <= 1.5 x ULT; 5. According to RECIST1.1, there was at least one measurable target lesion; 6. Women must take effective contraceptive measures during the study period and within 6 months after the end of the study; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 7. Understand and sign informed consent voluntarily with good compliance. Exclusion Criteria: 1. The function of liver and kidney was seriously abnormal; 2. Preparation for pregnant, pregnant and lactating women; 3. Inability to lie flat for half an hour; 4. Suffering from claustrophobia or other mental disorders; 5) Other researchers considered it unsuitable to participate in the trial. -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
18F-FDG
All study participants will undergo one 18F-FDG PET/ CT scan.

Locations

Country Name City State
China Beijing Cancer Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary MPR In the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%. [Time Frame: After 2-4 cycles of immunotherapy (each cycle is 28 days)]
Secondary PFS progression free survival 2 years
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