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

June 3, 2024 updated by: Fenglin Liu, Fudan University

Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma: the Phase 2 Solids-01 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Fudan University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surufatinib，sintilimab and SOX chemotherapy
Surufatinib: 250mg qd，d1-21, q3w; Surufatinib: 200mg, ivdrip, d1, q3w; SOX: Oxaliplatin+S-1 S-1:40~60mg Bid, d1~14, q3w; Oxaliplatin: 130mg/m2, ivdrip,d1, q3w; Neoadjuvant therapy for 2-4 cycles, adjuvant therapy for 3-5 cycles. After 6 cycles of SOX chemotherapy, Surufatinib + Surufatinib was taken orally until one year.
Drug: Surufatinib
Surufatinib: 250mg qd，d1-21, q3w
Drug: Sintilimab
Sintilimab：200mg ivdrip, d1, q3w
Drug: Oxaliplatin
130mg/m2，iv drip for 2h，d1, q3w
Drug: S1
S1：40~60mg Bid，d1~14, q3w

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOLIDS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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