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Phase III Trial of neoadjuvant chemotherapy with Three drugs for advanced gastric cancer: a multicenter, open, randomized, controlled clinical study

Phase III Trial of neoadjuvant chemotherapy with Three drugs for advanced gastric cancer: a multicenter, open, randomized, controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004983
Enrollment
Unknown
Registered
2014-07-16
Start date
2014-07-17
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Advanced gastric cancer

Interventions

A:Preoperative chemotherapy of DOX for 4 cycles, capecitabine 1000mg/m2, bid, p.o, 1 to 14 days
oxaliplatin 130mg/m2, ivgtt, 2h, d1, docetaxel 60mg/m2, ivgtt, d1, 21 day/cycle, operation after 2~4 weeks, and postoperative chemotherapy of XP for 4cycles after surgery
B:Preoperative chemotherapy of XP for 4 cycles, capecitabine 1000mg/m2, bid, p.o, 1 to 14 days
oxaliplatin 130mg/m2, ivgtt, 2h, d1, 21 day/cycle, operation after 2~4 weeks, and postoperative chemotherapy of XP for 4cycles after surgery
C:Operation after 2~4 weeks, and postoperative chemotherapy of XP for 8cycles after surgery, capecitabine 1000mg/m2, bid p.o, 1 to 14 days
oxaliplatin 130mg/m2, ivgtt, 2h, d1

Sponsors

Hebei Medical University affiliated Fourth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Endoscopy, CT and other tests determined to be in advanced gastric cancer; 2. Biopsy diagnosed as gastric adenocarcinoma; 3. All patients required EUS, CT (or PET-CT) and laparoscopic staging assessment before treatment, according to the 7th edition AJCC, staging III; 4. Patients with MDT consultation identified as potentially resectable cases, with no procedure-related contraindications, expected to surgical resection; 5. Karnofsky score more than 80, ECOG score 0-1; 6. Expected survival longer than 6 months; 7. Male and female aged 20 to 60 years old; 8. According to RECIST 1.1: have measurable disease; 9. signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with kidney dysfunction accompanied, cardiovascular system and other serious diseases, affecting chemotherapy or surgery; 2.Allergy with capecitabine, oxaliplatin, docetaxel and excipients; 3. Received any form of chemotherapy or other investigational drug before enrolled; 4. Patients in child-bearing period are not willing to take contraceptive measures; women with pregnancy and lactation; 5. Patients associated with dysphagia, active peptic ulcer, incompleteness intestinal obstruction, active gastrointestinal bleeding, perforation caused difficulties oral for apecitabine; 6. Patients with other tumors combined.

Design outcomes

Primary

MeasureTime frame
pathological complete response rate(PCR;

Secondary

MeasureTime frame
Objective response rate (ORR);R0-resection rate;3-years Disease-free survival(DFS);3-years over survival rate;Safety;

Countries

China

Contacts

Public ContactQun Zhao
zhaoqun516@126.com+86 13930162111

Outcome results

None listed

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