Clinical trial · Observational

Effect of Combination Therapy on SCLC After Initial Treatment Failure

Effect of Radiotherapy Concurrent With PARP Inhibitor + Temozolomide Combined With Immune Checkpoint Inhibitor on SCLC After Initial Treatment Failure

NCT04790955CI-TRIAL-00050602unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

SCLC patients after initial treatment failure are treated with SBRT and low-dose radiotherapy concurrent with PARP inhibitors + temozolomide +PD-1/PD-L1 inhibitors for two cycles at least, then PARP inhibitors+temozolomide+PD-1/PD-L1 inhibitors two cycles, PD-1/PD-L1 inhibitors maintenance therapy lasted for up to 2 years.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Small-cell Lung Cancer	Lung Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (0)

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Primary outcomes (3)

measure
3 Month Objective Remission Rate
timeFrame
Up to 5 years
description
The patients have complete remission and partial remission on 3 months after radiotherapy and chemotherapy.
measure
Progression-Free Survival
timeFrame
From chemotherapy completion until progress or death, assessed up to 5 years
description
Will be described using standard Kaplan-Meier methodologies. The median PFS time, 1-year rate, 3-year PFS rate and 5-year PFS rate will be estimated and presented with 90% confidence intervals.
measure
Time To Progression
timeFrame
Up to 5 years
description
Time involved from research start until progress for tumor

Secondary outcomes (2)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

Inclusion Criteria:

Age ≥18 years old, ≤80 years old, expected survival ≥3 months;Pathologically confirmed SCLC with recurrence and metastasis after initial treatment;KPS score ≥70 points;Satisfied the following laboratory diagnostic indicators: hemoglobin ≥110g/L, leukocyte 4.0-10.0×109/L, neutrophils 2.0-7.5×109/L, platelet ≥100×109/L;Creatinine ≤ upper normal limit (UNL);ALT and AST≤2.5×UNL, alkaline phosphatase (ALP) ≤5×UNL, total bilirubin (TBIL) ≤ UNL;Signed informed consent.

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Exclusion Criteria:

1. Pregnant or lactating women;
2. Secondary tumor;
3. HIV carriers;
4. Serious medical diseases such as heart and lung;
5. Patients with uncontrollable mental history, unable to cooperate with treatment;
6. Autoimmune system disease, symptomatic interstitial lung disease;
7. Patients with active infection, chronic infection, acute infection, etc., and body inflammation;
8. Patients who had used hormones or antibiotics 1 month prior to treatment. -

References

Publications (0)

Data not yet available

No reference posted for this study.