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Accurate efficacy evaluation system for transformation therapy in patients with unresectable gastric cancer

Accurate efficacy evaluation system for transformation therapy in patients with unresectable gastric cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024118
Enrollment
Unknown
Registered
2019-06-26
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-07-01

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

Conditions

Gastric adenocarcinoma (STAD)

Interventions

Case series:Transformation therapy

Sponsors

Shandong Provincial Hosptial
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. confirmed by pathology (including histology or cytology) as gastric adenocarcinoma, and meet one of the following conditions: Tumor invasion of surrounding organs (T4b); N3 lymph node metastasis; extensive or fusion into a cluster of lymph node metastasis Krukenburg tumor; liver and lung oligometastasis, etc.; 3. Before surgery, CT/MRI or color Doppler ultrasound, PET-CT, if necessary, laparoscopic exploration to identify the above unresectable gastric cancer; 4. Newly diagnosed patients who have not received radiochemotherapy, targeted therapy or immunotherapy 5. ECOG PS 0-1; 6. Estimated survival time >= 6 months; 7. no serious heart, lung, liver dysfunction; no jaundice and digestive tract obstruction; no acute infection 8. The main organs function normally and meet the following criteria: (1) Blood routine examination criteria must meet: (no blood transfusion within 14 days) HB>=100g/L; WBC>=3.5x10^9/L; ANC>=1.5x10^9/L; PLT>=100x10^9/L; (2) Biochemical examinations must meet the following criteria: BIL 60ml/min (Cockcroft-Gault formula); 9. did not participate in other clinical studies before and during treatment; 10. Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.

Exclusion criteria

Exclusion criteria: 1) There are distant metastases such as lung, brain, bone, and peritoneum, except for liver oligometastase; 2) Her-2 positive test, patients who are willing to receive Herceptin treatment; 3) At the same time, there are other serious diseases that are difficult to control: including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction below 50%, difficult to control hypertension (with high blood pressure, can not be reduced to normal range by antihypertensive drugs): systolic blood pressure > 140mmHg / diastolic blood pressure > 90mmHg), renal insufficiency, etc. 4) Other medical treatments (including Chinese medicines) have been carried out before enrollment or cannot be guaranteed according to research requirements after enrollment. 5) Allergic to the drug of this program; 6) Pregnant or lactating women, who have fertility requirements during the study period; 7) The investigator believes that it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
R0 resection rate;

Secondary

MeasureTime frame
overall survival;objective response rate;disease control rate;Disease-free survival;safety;

Countries

China

Contacts

Public ContactYueping Li

Shandong Provincial Hosptial

lileping@medmail.com.cn+86 13356662129

Outcome results

None listed

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