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Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Gastric/Gastroesophageal Junction Adenocarcinoma

ConditionsGastric CancerGastro Esophageal Junction Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

signed informed consent

patients age 18-75 years;

Histologically CT/MRI confirmed cT3-4bNanyM0 gastric or GEJ adenocarcinoma;

ECOG 0-1, no surgery contraindications;

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Surufatinib

    Drug

    Surufatinib: 250mg qd，d1-21, q3w

  • Sintilimab

    Drug

    Sintilimab：200mg ivdrip, d1, q3w

  • Oxaliplatin

    Drug

    130mg/m2，iv drip for 2h，d1, q3w

  • S1

    Drug

    S1：40\~60mg Bid，d1\~14, q3w

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Surufatinib，sintilimab and SOX chemotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response（pCR）rate

Time frame
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks

Secondary outcomes

1

R0 resection rate

Time frame
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
2

Disease free survival (DFS)

Time frame
From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
3

Overall survival (OS)

Time frame
From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: