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Canceled by the investigator. A prospective, single-arm clinical trial of tislelizumab combined gemcitabine and oxaliplatin in the first-line treatment of patients with peripheral T cell lymphoma

A prospective, single-arm clinical trial of tislelizumab combined gemcitabine and oxaliplatin in the first-line treatment of patients with peripheral T cell lymphoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039372
Enrollment
Unknown
Registered
2020-10-25
Start date
2020-11-01
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

Peripheral T cell lymphoma

Interventions

therapy group:tislelizumab combined with gemcitabine and oxaliplatin

Sponsors

The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with PTCL confirmed by histopathology (excluding ALK + anaplastic large cell lymphoma and mycosis fungoides); 2. Patients aged 18-70 years; 3. Patients with ECoG score of 0-2; 4. Patients with expected survival > 12 weeks; 5. Patients with at least one measurable disease site; 6. Patients with normal cardiopulmonary function; 7. Women of childbearing age were negative in urine or blood pregnancy test within 7 days, and male and female patients should agree to use effective contraceptive measures during the treatment period and the following year; 8. Patients who volunteered to participate in this study, signed informed consent before screening, and were willing to follow and able to complete all trial procedures.

Exclusion criteria

Exclusion criteria: 1. Those patients with lymphoma involving the central nervous system; 2. Patients who have received PD-1 antibody or PD-L1 antibody or CTLA4 monoclonal antibody in the past; 3. Patients who have received radiotherapy or chemotherapy for lymphoma in the past; 4. Patients who underwent major surgery within 3 weeks after the study; 5. Patients with malignant tumors other than NHL; 6. Women of childbearing age with recent family planning; 7. Patients with active systemic infection; 8. Suspected HIV / AIDS patients; 9. Patients with uncontrollable or serious cardiovascular diseases; 10. Patients who may be allergic, allergic or intolerant to the study drug; 11. Patients with previous interstitial lung disease; 12. Patients with serious diseases that may interfere with the study; 13. Patients treated with another research drug at the same time; 14. According to the judgment of the researcher, the patients were not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Overall response rate;

Secondary

MeasureTime frame
Progression Free Survival;Duration of Response;disease-control rate;Overall Survival;Adverse events;

Countries

China

Contacts

Public ContactZhiyong Zeng

The First Affiliated Hospital of Fujian Medical University

zengzhiyong049@163.com+86 13799426491

Outcome results

None listed

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