Clinical trial · Interventional
Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer
Apatinib Combined With Oxaliplatin and Gimeracil and Oteracil Porassium Capsules Neoadjuvant Therapy for Locally Advanced Gastric Cance: A Multicentre, One-armed, Clinical Pilot Trial
NCT03192735CI-TRIAL-00043150unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We star a multicentre, one-armed, clinical pilot trial intends to investigate the safety and effectiveness of Apatinib Combined With Oxaliplatin, Gimeracil and Oteracil Porassium Capsules Neoadjuvant Ttherapy for Locally Advanced Gastric Cancer(cT2-4/N+M0)
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Apatinib Combined | — | UNRESOLVED | — |
| Locally Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
| SOX | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ApatinibMesylateTablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib Combined With SOX
- description
- In this group,subject will be given ApatinibMesylateTablets 500mg one time a day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 one time a day,ivgtt,in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:\<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; \>1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.
- interventionNames
- Drug: ApatinibMesylateTablets
Primary outcomes (1)
- measure
- Radical surgical resection rate
- timeFrame
- 30 days
- description
- Radical surgical resection rate is defined as the rate of R0 resection
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
1. Age from 18 to 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. cT2-4N+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
4. No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
5. Performance status of 0 or 2 on Eastern Cooperative Oncology Group scale (ECOG)
6. Without previous surgical, chemotherapy,radiotherapy, immunotherapy, or targeted therapy for gastric cancer.
7. Estimate life is equal or greater than 3 months
8. No serious heart, lung, liver dysfunction;no Jaundice and obstruction of the digestive tract; no acute infection
9. The main organ function is normal,and meet the following criteria:
* blood routine examination( No blood transfusion within 14 days)
1. HB≥100g/L,
2. WBC≥3.5×109/L
3. ANC≥1.5×109/L,
4. PLT≥100×109/L;
* blood biochemical examination
1. BIL \<1.5 Upper Limit Of Normal(ULN),
2. ALT and AST\<2.5ULN,GPT≤1.5×ULT;
3. Cr≤1ULN,creatinine clearance\>60ml/min(Cockcroft-Gault formula)
10. Written informed consent
Exclusion Criteria:
1. Pregnant and lactating women
2. Suffering from severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
4. History of previous chemotherapy or radiotherapy therapy
5. History of other malignant disease within the past 5 years
6. History of previous neoadjuvant chemotherapy or radiotherapy
7. History of unstable angina or myocardial infarction within the past 6 months
8. History of cerebrovascular accident within the past 6 months
9. History of continuous systematic administration of corticosteroids within 1 month
10. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
11. Patients with a clear tendency of gastrointestinal bleeding,such as: active ulceration,fecal occult blood test(++),The history of hematemesis and melena within 2 months,coagulation disorders(INR\>1.5、APTT\>1.5 ULN).
12. Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content\>1.0g)
13. There are several factors that affect oral medicine,such as unable to swallow, uncontrollable nausea and vomitin, or chronic diarrhea and intestinal obstruction
14. Drug allergy to experimental medicineReferences
Publications (1)
- DERIVEDLin JX, Xu YC, Lin W, Xue FQ, Ye JX, Zang WD, Cai LS, You J, Xu JH, Cai JC, Tang YH, Xie JW, Li P, Zheng CH, Huang CM. Effectiveness and Safety of Apatinib Plus Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer: A Nonrandomized Controlled Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116240. doi: 10.1001/jamanetworkopen.2021.16240. PMID 34241629