Gastric CancerPhase 2NCT06447636

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

A Phase 2 study testing Surufatinib, Sintilimab and Oxaliplatin in people with Gastric Cancer and Gastro Esophageal Junction Cancer, run by Fudan University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastric Cancer, Gastro Esophageal Junction Cancer
What is being tested?: Surufatinib, Sintilimab and Oxaliplatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: 30 Sep 2024to 30 May 2029
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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

Show all 11Show fewer

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;

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Cancer Hospital
Shanghai

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions: Gastric Cancer, Gastro Esophageal Junction Cancer
Being tested: Surufatinib, Sintilimab, Oxaliplatin, S1
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SurufatinibDrug
Surufatinib: 250mg qd，d1-21, q3w
SintilimabDrug
Sintilimab：200mg ivdrip, d1, q3w
OxaliplatinDrug
130mg/m2，iv drip for 2h，d1, q3w
S1Drug
S1：40~60mg Bid，d1~14, q3w

Study groups in NCT06447636
Study group	Role	What they receive
Surufatinib，sintilimab and SOX chemotherapy	Experimental	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. Receives: Drug: Surufatinib; Drug: Sintilimab; Drug: Oxaliplatin; Drug: S1

What is being measured

The primary outcome is the main question the study is designed to answer.

Pathological complete response（pCR）rate
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks

Secondary outcomes (3)

R0 resection rate
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Event free survival (EFS)
EFS is defined as the time from enrollment to disease progression, recurrence, or death from any cause, whichever occurs first.
Measured: 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)
OS is defined as the time from enrollment to death from any cause.
Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented date of death from any cause, assessed up to 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 202430 May 2029

First posted7 Jun 2024
Study start30 Sep 2024
Primary completion30 May 2026
Study completion30 May 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastric CancerStudies of the same condition, open and under way.
More trials run by Fudan UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06447636
Sponsor's protocol ID: SOLIDS-01
Status last verified: Jul 2026
First submitted: 3 Jun 2024
Last updated: 5 Aug 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma: the Phase 2 Solids-01 Trial
ClinicalTrials.gov ID: NCT06447636
Acronym / sponsor ID: SOLIDS-01
Conditions: Gastric Cancer, Gastro Esophageal Junction Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 20 participants (estimated)
Lead sponsor: Fudan UniversityUniversity, hospital or other
Study start: 30 Sep 2024 (actual)
Primary completion: 30 May 2026 (actual)
Study completion: 30 May 2029 (estimated)
First posted: 7 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Surufatinib，sintilimab and SOX chemotherapy	Experimental	Drug: Surufatinib, Drug: Sintilimab, Drug: Oxaliplatin, Drug: S1Surufatinib: 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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;

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SurufatinibSurufatinib: 250mg qd，d1-21, q3w	Drug	Surufatinib，sintilimab and SOX chemotherapy
SintilimabSintilimab：200mg ivdrip, d1, q3w	Drug	Surufatinib，sintilimab and SOX chemotherapy
Oxaliplatin130mg/m2，iv drip for 2h，d1, q3w	Drug	Surufatinib，sintilimab and SOX chemotherapy
S1S1：40~60mg Bid，d1~14, q3w	Drug	Surufatinib，sintilimab and SOX chemotherapy

Primary outcome

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

3 secondary outcomes

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.
Event free survival (EFS)
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.
Overall survival (OS)
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented date of death from any cause, assessed up to 3 years.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Individual participant dataSharing planned: No

Related trials for Gastric Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
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Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
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Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surufatinib, Sintilimab and Oxaliplatin in people with Gastric Cancer and Gastro Esophageal Junction Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06447636.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.