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Status unknownNCT04351867Updated Jul 16, 2020

A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer

A Phase 3 interventional study of docetaxel plus oxaliplatin and capecitabine and oxaliplatin plus capecitabine in Stomach Neoplasms, sponsored by LiNing. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-07-16.

Sponsored by LiNing · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
196
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

This study was a prospective, randomized, controlled phase III clinical study to evaluate the efficacy and safety of docetaxel plus oxaliplatin and capecitabine versus oxaliplatin plus capecitabine in the treatment of gastric or gastroesophageal junction adenocarcinoma with postoperative pathological stage IIIB and IIIC.

Read the detailed description

In 2019, CSCO guidelines grade I recommend gastric or gastroesophageal junction adenocarcinoma patients, after D2 R0 resection, whose postoperative pathological stage was III treated with XELOX as an adjuvant chemotherapy. However, some retrospective clinical studies in China suggest that the 3-year DFS rate of XELOX program as an adjuvant postoperative chemotherapy program is still low, and the risk of recurrence is higher for patients with postoperative pathological stage IIIB/IIIC.In recent years, the success of the JACCRO GC-07 trial has provided evidence for the value of Taxoids in postoperative adjuvant therapy of gastric cancer. In the FLOT4 trial, the FLOT improved the DFS rate by 3 years compared with the ECF/ECX. At present, there is no clinical study data to prove whether the combined three-drug regimen can further reduce the risk of postoperative recurrence and improve the treatment effect compared with oxaliplatin combined capecitabine two-drug regimen for patients with high postoperative recurrence risk (patients with postoperative pathological stage IIIB/IIIC). Therefore, the investigators carried out this trial.

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Conditions studied

  • Stomach Neoplasms

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 196 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

LiNing is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have signed the informed consent and can comply with the visit and related procedures stipulated in the program
  • Age ≥18 years old and ≤75 years old
  • D2 radical resection was performed within 21-60 days before the beginning of the first cycle of chemotherapy in this clinical study
  • Preoperative neoadjuvant chemotherapy was not performed and Gastric and gastroesophageal junction adenocarcinoma (including signed-ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) at stage IIIB and IIIC were confirmed by postoperative pathological staging. Note: the presence of distant metastases should be confirmed by a CT or MRI scan.ECT should be performed if bone metastases are suspected.If peritoneal metastases are suspected, laparoscopy should be performed
  • Postoperative ECOG score was 0 or 1
  • Leukocyte ≥ 4×109/L, platelet ≥ 100×109/L without blood transfusion, neutrophil absolute value (ANC) ≥ 1.5×109/L without granulocyte stimulating factor treatment, and hemoglobin ≥ 90 g/L
  • Bilirubin ≤ 1.5 times of the upper limit of normal value, glutamic oxalacetic transaminase and glutamic-pyruvic transaminase ≤ 2.5 times of the upper limit of normal value
  • Serum creatinine ≤ 1.5 times the upper limit of normal value, or GFR>45 ml/min
  • Serum albumin ≥ 25 g/L (2.5g /dL)
  • INR or PT ≤ 1.5 times ULN
  • Hepatitis b surface antigen positive patients need to be tested for hepatitis b DNA virus quantitative detection, only \< the upper limit of the normal detection value can be included in the group, and should long-term use of anti-hepatitis b drugs
  • Tumor specimens can be provided for consultation (if the patient's surgical specimen comes from another hospital), protein and gene testing

Exclusion criteria

Exclusion Criteria:

  • Postoperative wound healing is poor and chemotherapy is not appropriate to start
  • Recurrent patients or suspected peritoneal metastases after radical surgery
  • Known DPD enzyme deficiency
  • Allergy to, or history of severe allergy to, or contraindication to any of the experimental drugs or its excipients
  • Patients who are expected to require major surgery during the study period
  • Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or CT-confirmed active pneumonia
  • Tested positive for HIV
  • Active hepatitis b or c
  • Only liquid diet was allowed after the operation, with BMI \<18kg/m2
  • Uncontrolled pain
  • A history of antitumor drug therapy other than radical surgery
  • Severe infection in the active stage or with poor clinical control
  • Use of hormones is contraindicated
  • Severe cardiovascular disease, myocardial infection or cerebrovascular accident, arrhythmia, unstable angina pectoris within 3 months before the trial
  • Uncontrollable increase in blood pressure or blood sugar
  • A history of other malignancies within 5 years, except for carcinoma in situ of the cervix, non-melanoma skin cancer, or stage I uterine cancer
  • Distant metastases are known
  • Peripheral neuropathy ≥ NCI CTCAE grade 2
  • Serum albumin \< 2.5 g/dL
  • Chronic enteritis
  • Any other disease for which there is evidence of a need to limit the use of experimental drugs
  • Participate in additional trials up to 30 days before the trial or plan to participate in additional trials while the trial is ongoing
  • Receive other experimental drugs up to 28 days before the start of the trial
  • Women who are pregnant or nursing, or who plan to become pregnant within five months of the end of treatment. Women of childbearing age should receive a blood/urine pregnancy test 7 days before the start of the trial
  • Clinically significant active bleeding
  • Patients who have trouble swallowing tablets
  • Previous allogeneic bone marrow transplant or organ transplant
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
196 participants (estimated)

Study arms

  • Experimental
    experimental group

    docetaxel plus oxaliplatin and capecitabine

    Drug: docetaxel plus oxaliplatin and capecitabine

  • Active comparator
    control group

    oxaliplatin plus capecitabine

    Drug: oxaliplatin plus capecitabine

Interventions

  • Drugdocetaxel plus oxaliplatin and capecitabine

    docetaxel 50mg/㎡ ivgtt. d1+oxaliplatin 100mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d

    Also known as: Three medicine combined

  • Drugoxaliplatin plus capecitabine

    oxaliplatin 130mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d

    Also known as: Two medicine combined

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What researchers measure

Primary outcomes

  1. disease free survival

    From the date of randomization until the date of the first recorded disease recurrence, metastasis or death from any cause, whichever came first.

    Time frame: up to three years.

Secondary outcomes

  1. overall survival

    From the date of randomization until the date of the first recorded death from any cause. For subjects lost to follow-up prior to death, the last follow-up time is usually calculated as the time of death.

    Time frame: up to three years.

  2. Adverse reaction

    Adverse reaction will be assessed by NCI CT CAE v5.0.

    Time frame: up to three years.

  3. Assessment of life quality

    Quality of life will be assessed using The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Cancer (QLQ-C30) and the site-specific module for gastric cancer (QLQ-STO22) . These tables will be usde together to assessed the quality of life of the patients. The higher the score, the worse the quality of life.

    Time frame: up to three years.

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Study locations

1 site
  • Henan Cancer Hospital
    Zhengzhou, Henan 450008, China
    • Ning Li, PhD · Contact · lining97@126.com · 0086-13526501903
    • Ning LI, PhD · Principal investigator
    • Suxia Luo, PhD · Principal investigator
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References and documents

Individual participant data

Plan to share: Yes — Raw data

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04351867
Lead sponsor
LiNing
Responsible party
LiNing (Chief Physician, Henan Cancer Hospital) — Sponsor-investigator
First posted
Apr 17, 2020
Start date
Sep 2020 (estimated)
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Jul 16, 2020

Study contacts

Ning Li, PhD
Contact
lining97@126.com
0086-13526501903
Ning Li, PhD
principal investigator · Henan Cancer Hospital
Suxia Luo, PhD
principal investigator · Henan Cancer Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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