Combining Surufatinib and Sintilimab for Advanced Gastric Cancer

An Open-label, Single Center, Phase II Study of Surufatinib Combined With Sintilimab in Patients With Advanced Adenocarcinoma of the Gastric or Gastrooesophageal Junction Adneocarcinoma Cancer

This study is testing a new combination of two medications, Surufatinib and Sintilimab, to see if they can help people with advanced stomach cancer who haven't had treatment before.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Lenvatinib, chemotherapy, radiation, Sintilimab, Surufatinib
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05235906 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Surufatinib in combination with Sintilimab for patients with advanced gastric adenocarcinoma. The study aims to determine how well this combination therapy works in treating patients who have not received prior treatment for their advanced disease. Participants will be monitored for measurable disease outcomes and overall health status throughout the trial. The study is designed for patients aged 18 to 75 with specific eligibility criteria to ensure safety and effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced or recurrent gastric adenocarcinoma who have not received prior therapy for their condition.

Not a fit: Patients with prior treatment for advanced gastric cancer or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gastric cancer.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches in targeting gastric cancer have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. Patients must have the ability to understand and voluntarily sign informed consent;
2. Age: 18-75 years old;
3. Patients have histologically or cytologically confirmed advanced or recurrent gastric or gastroesophageal junction adenocarcinoma;
4. NO previous therapy for advanced/metastatic disease of GC/GEJ and CPS≥1;
5. Patients have measurable disease as defined by RECIST 1.1 as determined by investigator;
6. Eastern Cooperative Group (ECOG) performance status of 0 to 2;
7. Has adequate organ function;
8. Expected survival period ≥ 3 months;
9. Patients who not received a blood transfusion within 7 days of registration;
10. Patients have recovered adverse events associated with chemotherapy, radiation and surgical operation as pretreatment to Grade 1 or lower with CTCAE v5.0 excluding stable symptoms (eg alopecia, peripheral sensory neuropathy, skin hyperpigmentation, dysgeusia etc.).
11. Patients capable of taking oral medication;
12. Female of childbearing potential who are negative in a pregnancy test within 7 days before enrollment. Both male and female patients should agree to use an adequate method of contraception (total abstinence, an intrauterine device or hormone releasing system, an contraceptive implant and an oral contraceptive) starting with the first dose of study therapy through 6 months after the last dose of study therapy. Duration will be determined when the subject is assigned to treatment.

Exclusion Criteria:

1. Patients who received prior anticancer treatment within 14 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 28 days prior to the first dose of study drugs.
2. Patients who have undergone surgical treatment and radiotherapy with in 2 weeks before enrollment.
3. Patients with a history of prior treatment with Lenvatinib or any anti-programmed death 1 (anti-PD-1), anti-programmed ligand death 1 (anti-PD-L1), or anti-programmed ligand death 2 (anti-PD-L2 agent).
4. Patients with symptomatic brain metastasis.
5. Patients with hypertension that is difficult to control (systolic blood pressure ≥150 mmHg and diastolic blood pressure ≥100 mmHg) despite treatment with several hypotensive agents.
6. Those who have received live vaccination within 4 weeks before the start of treatment.
7. Patients with active hepatitis.
8. Patients with a history of human immunodeficiency virus (HIV).
9. Patients were judged unsuitable as subject of this trial by investigator.

Where this trial is running

Guangzhou, Guangdong

• Cancer center of SunYat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Dongsheng Zhang, PhD

Conditions Gastric Adenocarcinoma