A Phase II Clinical Study of Surufatinib Combined With Sintilimab in the Treatment of Advanced Gastric Cancer

Gastric Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235906
• Other study ID #: HMPL-012-SPRING-G104
• Status: Recruiting
• Phase: Phase 2
• Start date: August 16, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: August 2023
• Source: Sun Yat-sen University
• Contact: Dongsheng Zhang, PhD
• Phone: 86-2087343795
• Email: zhangdsh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The efficacy and safety of the use of Surufatinib in combination with Sintilimab.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma

Intervention

Drug:
• Surufatinib+Sintilimab
Surufatinib at a dose of 250mg Qd, with humanized anti-PD-1 monoclonal antibody Sintilimab injected intravenously 200mg per 3 weeks until disease progresses or unacceptable tolerability occurs.

Locations

Country	Name	City	State
China	Cancer center of SunYat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST	up to 12 months
Secondary	Disease control rate (DCR)		up to 12 months
Secondary	Progression-free survival (PFS)		up to 12 months
Secondary	Overall survival (OS)		up to 24 months