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The relationship between responses to ICB treatment and differentiation of lymphocytes in solid tumor patients: a prospective and non-interventional study

The relationship between responses to a-PD-1 treatment and differentiation of lymphocytes in solid tumor patients: a prospective and non-interventional study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060733
Enrollment
Unknown
Registered
2022-06-09
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

Solid tumor

Interventions

immunotherapy:Immune checkpoint inhibitors

Sponsors

Jiangsu Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years old, male or female; 2. The patients are diagnosed as solid tumor via histologic and cytology; 3. Clinical stage is stage IIIB-IV; 4. Have one measurable lesions at least according to RECIST 1.1 standard; 5. ECOG PS 0-1; 6. The expected lifetime of patients should be more than 3 months; 7. No previous ICB antitumor therapy; 8. Biochemical examination should meet the following criteria: (1) TBIL = 40mL/min; 9. The main viscera function of patients should meet the following requirements: (1) Hb >= 9.0 g/dL; (2) ANC >= 1.5 x 10^9/L; (3) PLT >= 100 x 10^9/L; 10. The patients are willing to join in this study, and have signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Tumors of the hematologic system; 2. A history of severe allergies, allergies or other allergic reactions to chimeric or humanized antibodies or fusion proteins; 3. Severe autoimmune disease; 4. Immunosuppressive drugs were administered 2 weeks prior to enrollment; 5. Oral dosage of more than 10mg of prednisone or isodose hormone per day; 6. Severe infections requiring antimicrobial treatment 2 weeks prior to enrollment; 7. Severe pulmonary dysfunction before enrollment; 8. Severe comorbidity precludes the possibility of treatment; 9. Other conditions considered inappropriate by the investigator.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;Safety;Progression Free Survival;disease control rate;Duration of Response;

Countries

China

Contacts

Public ContactShen Bo

Jiangsu Cancer Hospital

shenbo987@126.com+86 13913910555

Outcome results

None listed

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