NCT04354662CompletedPhase 2
Toripalimab Combined With FLOT Neoadjuvant Chemotherapy in Patients With Resectable Gastric Cancer
Phase II Study of Toripalimab Combined With Fluorouracil, Leucovorin, Oxaliplatin and Docetaxel (FLOT) in Patients With Locally Advanced, Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
Gastric cancer is one of the most common malignant tumors of the digestive tract. Gastric cancer patients diagnosed for the first time in China have a higher proportion of advanced stages and a higher postoperative metastasis rate. Studies have shown that patients with good pathological response after preoperative neoadjuvant therapy (such as tumor regression grade, TRG0 or 1) have a better prognosis. The AIO-FLOT4 study found that preoperative perioperative FLOT chemotherapy not only prolonged the progression-free survival (PFS) time and overall survival (OS) time of patients with advanced gastric cancer, but also increased postoperative pathological remission rate. How to further improve the efficacy of the perioperative treatment plan may be beneficial to improve the long-term survival of gastric cancer patients. Several clinical studies have also confirmed that PD-1 antibody significantly prolongs the life of gastric cancer patients who have failed advanced chemotherapy in the back-line treatment. Thus the investigators plan to conduct this clinical trials to evaluate the safety and efficacy of Toripalimab (PD-1 antibody) combined with FLOT regimen in the perioperative period.The secondary end points included pathological remission rate, resection rate, D2 radical resection rate, 5-year disease-free survival (DFS) rate and 5-year OS rate.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 15 Apr 2020
- Start date
- 25 May 2020
- Primary completion date
- 31 Aug 2022
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04354662
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 51
- From 25 May 2020 to the primary completion date, 31 Aug 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous organ transplantation or HIV patients;
Other illness
- Recurrent or residual gastric cancer;
- Having or having had autoimmune disease;
- Allergy or contraindications to Toripalimab, 5- Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel;
- Malignant secondary disease;
- Severe non-surgical disease or acute infection;
- Obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency and severe gravity valve disease;
Other
- Distant metastasis or local invasion of adjacent organs;
- Peripheral polyneuropathy \> NCI grad I;
- Blood system, liver and kidney function were damaged;
- Symptomatic brain metastasis;
- Psychotic subjects who are not easy to control;
- Pregnant or lactating subjects.
Who the study is looking for
- locally advanced (\>T1) and/or nodal positive (N+) histologically proven adenocarcinoma of the gastric or gastroesophageal junction without distant metastases (M0)
- no previous surgical resection
- no previous cytostatic chemotherapy
- Age \> 18 years, no more than 75 years (female and male)
- Karnofsky Performance Status score of physical condition is 80-100
- surgical resectability
- Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy
- Leucocytes \> 4.000/µl
- Platelets \> 100.000/µl
- Serum creatinin ≤ 1.5x of normal value, or Creatinin-Clearance \> 50 ml/min
- written informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.