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Efficacy and Safety Trial of XiaoLiu Formula Combined with Gemcitabine-Based Regimen in the Treatment of R/R DLBCL: A Non-Randomized, Concurrent, Controlled, Multicenter Clinical Study

Efficacy and Safety Trial of XiaoLiu Formula Combined with Gemcitabine-Based Regimen in the Treatment of R/R DLBCL: A Non-Randomized, Concurrent, Controlled, Multicenter Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005925
Enrollment
Unknown
Registered
2022-04-27
Start date
2022-05-15
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

relapsed/refractory DLBCL

Interventions

Group Chinese and Western medicine:XiaoLiu Formula combined with gemcibine-based regimen
Group Western mendicine:gemcibine-based regimen

Sponsors

Shanxi Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age > 18 years, expected survival =3 months; (2) DLBCL patients who meet the western medicine diagnostic criteria and TCM syndrome type diagnostic criteria and have been diagnosed pathologically or cytologically; (3) Willing to accept the treatment; (4) Those who are not suitable for or unwilling to undergo autologous hematopoietic stem cell transplantation; (5) No other primary tumors and serious heart, liver and kidney diseases; (6) Those who have the telephone number and address of follow-up, are willing to cooperate with follow-up, have relatively complete medical records, and have signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Have been diagnosed with malignancies other than non-Hodgkins' lymphoma; (2) Pregnant or lactating women; (3) Unable or unwilling to receive TCM treatment; (4) Dysfunction of heart, liver, kidney and other organs; (5) Hepatitis active stage; (6) There are obvious signs or symptoms of inflammation; (7) Consciousness and mental disorders, lack of independent judgment ability.

Design outcomes

Primary

MeasureTime frame
Quality of Life;overall survival;Progression-Free Survival;TCM Symptom Score;

Secondary

MeasureTime frame
size of tumor;inflammation state;Card-style functional status score;Tumor burden index;

Countries

China

Contacts

Public ContactZhang Fupeng
55571482@qq.com15110387372

Outcome results

None listed

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