Gastric CancerPhase 2NCT06454435

Conversion Therapy of Sintilimab in Combination With Fruquintinib and Chemotherapy Versus Sintilimab and Chemotherpay in Stage IV Gastric Cancer

A Phase 2 study testing Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel and Sintilimab + S-1 plus nab-paclitaxel in people with Gastric Cancer and Gastric Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This is a multicenter, randomized, open-label, phase 2 clinical study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of fruquintinib and chemotherapy (S-1 plus nab-paclitaxel) versus sintilimab and chemotherapy as conversion therapy in patients with stage IV gastric… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Gastric Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
What is being tested?: Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel and Sintilimab + S-1 plus nab-paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 1 siteChina
Study dates: Jun 2024to Jun 2027
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed gastric/gastroesophageal junction adenocarcinoma through gastroscopy.
Ages: 18-70 Years (concluding 18 and 70 Years)
Life expectancy ≥3 months.
Treatment-naive Stage IV (clinical staging, AJCC 8th) unresectable patients, no prior antitumor therapy (including radiation, chemotherapy, targeted therapy or immunotherapy, etc.).
The Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0-1.
Preoperative examinations using CT, MRI, PET-CT, etc., indicating only one unresectable factor OR peritoneal metastasis with another unresectable factor, such as:

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N3 lymph node metastasis, mainly referring to group 16 lymph node metastasis.
Extensive or bulky lymph nodes (D2)
Locally advanced T4b.
Hepatic metastases (H1): ≤5 lesions with a total diameter ≤8cm.
Peritoneal metastasis (CY1, P1).
Ovarian metastasis (Krukenberg tumor).
Physically fit for major abdominal surgery.
Adequate organ and marrow function, defined as:
Hematological status: Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥100×10^9/L; Hemoglobin (HGB) ≥9.0 g/dL.
Liver function: For patients without liver metastasis, serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); ALT and AST ≤2.5×ULN. For patients with liver metastasis: TBIL ≤1.5×ULN; ALT and AST ≤5×ULN.
Renal function: Creatinine clearance (Ccr) ≥50 mL/min (calculated using the Cockcroft/Gault formula).
Adequate coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 times ULN.
Voluntary participation and signed informed consent with expected good compliance and follow-up.
Not involved in other clinical trials.
Willing to provide blood and histological samples.
No serious conditions affecting anesthesia, or surgery.
No hematologic disorders affecting postoperative hemoglobin levels.

Who cannot join

Has distal metastases other than oligometastases as defined in the inclusion criteria, such as pulmonary metastases, brain metastases, bone metastases, etc.
HER-2 positive patients or willing to receive Trastuzumab.
Endoscopic signs of active bleeding from the lesion.
Patients with moderate/large volume of ascites.
Near-obstruction at the cardia or pylorus affecting feeding and gastric emptying or difficulty swallowing tablets.
Concurrently suffering from other serious illnesses that are difficult to control (Severe uncontrolled recurrent infections, atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction measurement under 50%, uncontrolled hypertension, renal insufficiency, symptomatic peripheral neuropathy, and NCI classification >II)

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Has already on other medications prior to enrollment or could not be assured of compliance after enrollment.
Allergy to any drugs in the regimen.
Women who are pregnant or breastfeeding and have childbearing potential but are not taking adequate contraceptive measures.
Organ transplant recipients requiring immunosuppression.
Patients without decision-making capacity or with psychiatric disorders.
Systemic treatment with Chinese herbal anti-tumor or immunomodulatory drugs (including thymosin, interferons, interleukins) within 2 weeks before the first dose.
Use of immunosuppressive drugs within 4 weeks before the first study treatment, excluding local steroids or physiological doses of systemic steroids.
Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment.
Has a diagnosis of autoimmune disease within the previous 2 years (Patients with vitiligo, psoriasis, alopecia areata, or Graves' disease who do not require systemic therapy within the last 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type I diabetes mellitus requiring only insulin replacement therapy are eligible for enrollment).
Known history of primary immunodeficiency.
Known to have active tuberculosis.
Has history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody . positive); untreated acute or chronic active hepatitis B or hepatitis C infection. Patients receiving antiretroviral therapy are eligible for enrollment on an individual basis as determined by the physician with monitoring of viral copy number.
Urinalysis indicating urine protein ≥2+ and 24-hour urine protein quantification >1.0g.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Han Liang, MD contact

18622221082

tjlianghan@126.com

China1 site

Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 210000
Han Liang, MD, 18622221082, tjlianghan@126.com

Other trials in China

About this study

Official title: Sintilimab Combined With Fruquintinib and Chemotherapy Versus Sintilimab and Chemotherapy for Conversion Therapy in Unresectable Stage IV Gastric Cancer: a National Multicenter Randomized Controlled Study

Conditions: Gastric Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Being tested: Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel, Sintilimab + S-1 plus nab-paclitaxel
Medical subject headings: Stomach Neoplasms

What participants receive

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

Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxelDrug
Drug: Sintilimab Sintilimab 200mg, D1, IV, Q3W 4-8 cycles Drug: Fruquintinib Fruquinitinib 4mg/d, QD, PO, D1-D14, Q3W 4-8 cycles Drug: S-1 BSA<1.25 m2, 40mg twice/day; BSA 1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, D1-D14, Q3W 4-8 cycles Drug: Nab-paclitaxel
- without peritoneal metastases: 260 mg/m2, IV, D1 for 3h, Q3W 4-8 cycles;
- with peritoneal metastases: 80mg/m2 IP, plus 180mg/m2, IV, D1, Q3W 4-8 cycles.
Sintilimab + S-1 plus nab-paclitaxelDrug
Drug: Sintilimab Sintilimab 200mg, D1, IV, Q3W 4-8 cycles Drug: S-1 BSA<1.25 m2, 40mg twice/day; BSA 1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, D1-D14, Q3W 4-8 cycles Drug: Nab-paclitaxel
- without peritoneal metastases: 260 mg/m2, IV, D1 for 3h, Q3W 4-8 cycles;
- with peritoneal metastases: 80mg/m2 IP, plus 180mg/m2, IV, D1, Q3W 4-8 cycles.

Study groups in NCT06454435
Study group	Role	What they receive
Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel	Experimental	Not described Receives: Drug: Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel
Sintilimab + S-1 plus nab-paclitaxel	Active comparator	Not described Receives: Drug: Sintilimab + S-1 plus nab-paclitaxel

What is being measured

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

R0-surgery conversion rate
The proportion of patients who underwent R0 surgery among all efficacy evaluable patients.
Measured: about 3 years

Secondary outcomes (8)

Pathological complete response (pCR)
The proportion of patients with a pathological complete response (ypT0\&N0) at the time of definitive surgery among all patients who underwent conversation surgery.
Measured: about 3 years
Major pathological response rate (MPR)
The proportion of patients with a major pathological response (≤10% residual viable tumor) at the time of definitive surgery among all patients who underwent conversation surgery.
Measured: about 3 years
Rate of downstaging
To determine the rate of ypT0 and ypN0, and downstaging ratio of preoperative imaging clinical stage compared with baseline.
Measured: about 3 years
Objective response rate (ORR)
The proportion of patients who achieved complete response (CR) or partial response(PR) per RECIST v1.1.
Measured: about 3 years
Disease control rate (DCR)
The proportion of patients who achieved CR, PR or stable disease(SD) per RECIST v1.1.
Measured: about 3 years
Overall survival (OS)
The time from the initial date of conversation therapy to the date of death due to any cause.
Measured: about 3 years
Progression-free survival (PFS)
The time from the initial date of conversation therapy to the date of first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: about 3 years
Adverse event (AEs)
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Incidence and grade of surgery-related complications will also be as assessed.
Measured: about 3 years

Timeline

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

Jun 2024Jun 2027

First posted12 Jun 2024
Study startJun 2024 (estimated)
Primary completionJun 2026 (estimated)
Study completionJun 2027 (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 Tianjin Medical University Cancer Institute and HospitalThe 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 158 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06454435
Sponsor's protocol ID: E20231573
Status last verified: May 2024
First submitted: 6 Jun 2024
Last updated: 12 Jun 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sintilimab Combined With Fruquintinib and Chemotherapy Versus Sintilimab and Chemotherapy for Conversion Therapy in Unresectable Stage IV Gastric Cancer: a National Multicenter Randomized Controlled Study
ClinicalTrials.gov ID: NCT06454435
Acronym / sponsor ID: E20231573
Conditions: Gastric Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 158 participants (estimated)
Lead sponsor: Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
Study start: Jun 2024 (estimated)
Primary completion: Jun 2026 (estimated)
Study completion: Jun 2027 (estimated)
First posted: 12 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel	Experimental	Drug: Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel
Sintilimab + S-1 plus nab-paclitaxel	Active comparator	Drug: Sintilimab + S-1 plus nab-paclitaxel

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Histologically confirmed gastric/gastroesophageal junction adenocarcinoma through gastroscopy.
Ages: 18-70 Years (concluding 18 and 70 Years)
Life expectancy ≥3 months.
Treatment-naive Stage IV (clinical staging, AJCC 8th) unresectable patients, no prior antitumor therapy (including radiation, chemotherapy, targeted therapy or immunotherapy, etc.).
The Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0-1.

Key exclusion criteria (19 listed)

Has distal metastases other than oligometastases as defined in the inclusion criteria, such as pulmonary metastases, brain metastases, bone metastases, etc.
HER-2 positive patients or willing to receive Trastuzumab.
Endoscopic signs of active bleeding from the lesion.
Patients with moderate/large volume of ascites.
Near-obstruction at the cardia or pylorus affecting feeding and gastric emptying or difficulty swallowing tablets.

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
Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxelDrug: Sintilimab Sintilimab 200mg, D1, IV, Q3W 4-8 cycles Drug: Fruquintinib Fruquinitinib 4mg/d, QD, PO, D1-D14, Q3W 4-8 cycles Drug: S-1 BSA<1.25 m2, 40mg twice/day; BSA 1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, D1-D14, Q3W 4-8 cycles Drug: Nab-paclitaxel * without peritoneal metastases: 260 mg/m2, IV, D1 for 3h, Q3W 4-8 cycles; * with peritoneal metastases: 80mg/m2 IP, plus 180mg/m2, IV, D1, Q3W 4-8 cycles.	Drug	Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel
Sintilimab + S-1 plus nab-paclitaxelDrug: Sintilimab Sintilimab 200mg, D1, IV, Q3W 4-8 cycles Drug: S-1 BSA<1.25 m2, 40mg twice/day; BSA 1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, D1-D14, Q3W 4-8 cycles Drug: Nab-paclitaxel * without peritoneal metastases: 260 mg/m2, IV, D1 for 3h, Q3W 4-8 cycles; * with peritoneal metastases: 80mg/m2 IP, plus 180mg/m2, IV, D1, Q3W 4-8 cycles.	Drug	Sintilimab + S-1 plus nab-paclitaxel

Primary outcome

R0-surgery conversion rate
Time frame: about 3 years
The proportion of patients who underwent R0 surgery among all efficacy evaluable patients.

8 secondary outcomes

Pathological complete response (pCR)
Time frame: about 3 years
Major pathological response rate (MPR)
Time frame: about 3 years
Rate of downstaging
Time frame: about 3 years
Objective response rate (ORR)
Time frame: about 3 years
Disease control rate (DCR)
Time frame: about 3 years
Overall survival (OS)
Time frame: about 3 years
Progression-free survival (PFS)
Time frame: about 3 years
Adverse event (AEs)
Time frame: about 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 12 Jun 2024.

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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.

Han Liang, MD contact

18622221082

tjlianghan@126.com

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

Questions about this trial

What is this clinical trial studying?

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 23 inclusion and 19 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: opening soon, as of the sponsor's last update on 12 Jun 2024. 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?

Contact Han Liang, MD (18622221082, tjlianghan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0-surgery conversion rate (time frame: about 3 years). 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 NCT06454435.

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 12 Jun 2024.