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Trial Title:
Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Gastric/Gastroesophageal Junction Adenocarcinoma
NCT ID:
NCT06447636
Condition:
Gastric Cancer
Gastro Esophageal Junction Cancer
Conditions: Official terms:
Adenocarcinoma
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Surufatinib
Description:
Surufatinib: 250mg qd，d1-21, q3w
Arm group label:
Surufatinib，sintilimab and SOX chemotherapy
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
Sintilimab：200mg ivdrip, d1, q3w
Arm group label:
Surufatinib，sintilimab and SOX chemotherapy
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
130mg/m2，iv drip for 2h，d1, q3w
Arm group label:
Surufatinib，sintilimab and SOX chemotherapy
Intervention type:
Drug
Intervention name:
S1
Description:
S1：40~60mg Bid，d1~14, q3w
Arm group label:
Surufatinib，sintilimab and SOX chemotherapy
Summary:
For locally advanced gastric and gastroesophageal junction adenocarcinoma (cT3-4bNanyM0),
perioperative PD-1 antibody combined with chemotherapy can downstage tumor stage,
increase the R0 resection rate, and may improve the long-term survival. Combination of
perioperative surufatinib, sintilimab and chemotherapy for locally advanced gastric and
gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to
increase response rate and therapeutic efficacy. Surufatinib, as the oral drug in this
study is a small molecule kinase inhibitor that mainly acts on vascular growth factor
receptor (VEGFR1, 2,3), fibroblast growth factor receptor 1(FGFR1) and colony stimulating
factor 1 receptor (CSF1R). It is a proprietary product developed by Hutchison Whampoa
Pharmaceutical (Shanghai, China) Co., LTD. Surufatinib has been approved for
neuroendocrine tumor. This study is a monocenter, single-arm phase 2 clinical trial to
evaluate tolerability, safety and efficacy of perioperative surufatinib in combination
with sintilimab and chemotherapy in locally advanced gastric and gastroesophageal
junction adenocarcinoma.
Detailed description:
The incidence of gastric and gastroesophageal junction adenocarcinoma is increasing in
China, and it is one of the most common malignant tumors in China. Surgery is the only
possible way to cure gastric and gastroesophageal junction adenocarcinoma, however, over
70-80% of gastric/gastroesophageal junction adenocarcinoma patients in China are in
advanced stage. Locally gastric/gastroesophageal junction adenocarcinoma (cT3-4bNanyM0)
could be cured by multi-disciplinary therapies including surgery, immunotherapy and
chemotherapy. Perioperative immunotherapy plus chemotherapy can downstage tumor T and N
stage, increase the R0 resection rate, and may improve the long-term survival. However,
the therapeutic effects still not satisfactory to date. Surufatinib, as the novel oral
antivascular targeting drug, has been proved to be effective in neuroendocrine tumor.
Combination of perioperative surufatinib and immunotherapy plus chemotherapy for locally
advanced gastric/gastroesophageal junction adenocarcinoma could be a novel therapeutic
strategy to increase response rate and therapeutic efficacy. This study is a monocenter,
single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of
perioperative surufatinib in combination with sintilimab and chemotherapy in locally
advanced gastric and gastroesophageal junction adenocarcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- signed informed consent
- patients age 18-75 years;
- Histologically CT/MRI confirmed cT3-4bNanyM0 gastric or GEJ adenocarcinoma;
- ECOG 0-1, no surgery contraindications;
- Expected survival ≥3 months;
Exclusion Criteria:
- signs of distant metastases
- Prior chemotherapy, radiotherapy, surgery for gastric cancer;
- Significant cardiovascular disease
- major surgical procedure within 4 weeks prior to initiation of study treatment
- current treatment with anti-viral therapy or HBV
- pregnancy or breastfeeding
- history of malignancy within 5 years prior to screening
- Present or history of any autoimmune disease or immune deficiency;
- Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent;
- There are active gastric and duodenal ulcers, ulcerative colitis and other
gastrointestinal diseases, or active bleeding in unresectable tumors.
- Poorly controlled hypertension or diabetes;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Cancer Hospital
Address:
City:
Shanghai
Country:
China
Start date:
August 1, 2024
Completion date:
August 2028
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06447636
