Clinical trial · Interventional

Transarterial Chemoembolization With Lipiodol in the Treatment of Initial Unresectable Gastric Cancer (GC)

NCT05361161CI-TRIAL-00058691unknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is a prospective, open-labelled study to evaluate the efficacy and safety of sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of Initial unresectable gastric cancer.

Conditions

Conditions (2)

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

Condition (as posted)	Mapped entity	Match	Confidence
Embolization	—	UNRESOLVED	—
Gastric Cancer	Malignant Gastric Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Transarterial Chemoembolization	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Transarterial Chemoembolization With Lipiodol for Initial Unresectable Gastric Cancer
interventionNames
1. Drug: Transarterial Chemoembolization

Primary outcomes (4)

measure
Efficacy evaluation
timeFrame
up to 3 years
description
Objective response rate (ORR): complete response (CR) + partial response (PR). Evaluation methods: Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Subjects must have measurable tumor lesions at baseline, and the efficacy evaluation criteria are divided into complete remission (CR), partial remission (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1 criteria. Complete Remission (CR): All target and non-target lesions disappeared, no new lesions; Partial Remission (PR): Compared with baseline, tumor burden decreased by ≥30%, and non-target lesions did not progress significantly , no new lesions; Stable Disease (SD): neither PR nor PD; Progressive Disease (PD): tumor burden increased by ≥20%, and the absolute value increased by at least 5mm, or non-target lesions progressed, or new lesions (reconfirm progression after at least 6 weeks).

Eligibility

Eligibility (as posted)

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

Show eligibility criteria text

Inclusion Criteria:

1. Pathological and imaging diagnosis of gastric adenocarcinoma with initial unresectable R0;
2. Age (18-80 years old) and gender are not limited;
3. No extragastric organ transfer;
4. No serious diseases of the heart, liver, lung, kidney and other organs;
5. Expected survival time \> 3 months;
6. Physical performance status score ECOG ≤1 point;
7. Females of reproductive age must have a negative pregnancy test; or male and female patients must agree to use effective contraception during treatment and within 1 year thereafter.

Exclusion Criteria:

1. Poor coagulation function, INR\>1.5, or ongoing anticoagulation therapy or known bleeding diseases;
2. WBC \<3000/mm3 or platelet count \<50000/mm3;
3. AST and/or ALT \> 3 times the upper limit of normal;
4. Comorbidities or social environment that can cause subjects to fail to follow the research plan or even endanger patient safety;
5. The patient has other primary tumors.

References

Publications (0)

Data not yet available

No reference posted for this study.