SHR-1701 + Rivoceranib (± SHR-2554) in Advanced GC After First-Line Immunotherapy Failure

ConditionsGastric Cancer (GC)Gastroesophageal Junction Adenocarcinoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorJingdong Zhang

About this trial

To investigate the efficacy of SHR-1701 combined with Rivoceranib, with or without SHR-2554, in patients with gastric or gastroesophageal junction adenocarcinoma who have progressed on or were intolerant to first-line immunotherapy-containing treatment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, male or female.

Histologically or pathologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.

Disease progression on or intolerance to a prior treatment regimen that contained an immune checkpoint inhibitor (ICI).

HER2-negative expression.

Disqualifiers

Gastrointestinal perforation and/or fistula within 6 months prior to treatment, or active gastrointestinal bleeding within 3 months.

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.

Known history of allergy to any component of the investigational drugs or their excipients.

Treatment with any other investigational agent within 4 weeks prior to the first dose of the study drug, or within 5 half-lives of the previous investigational agent (whichever is longer).

Trial design

Design model

Parallel

Treatments tested in this trial

SHR-1701+Rivoceranib + SHR-2554
Drug
Drug: SHR-1701 Administered by intravenous (IV) infusion on Day 1 of each 21-day cycle. The infusion time should be controlled between 30 and 60 minutes, and must not exceed 2 hours. Drug: Rivoceranib Administered orally (PO) once daily (QD), continuously. Administration Instructions: To be taken orally with warm water, approximately 30 minutes after a meal. The daily dosing time should be consistent. Drug: SHR-2554 Administered orally (PO) twice daily (BID). Administration Instructions: Can be taken before or after meals, but administration approximately 30 minutes after morning and evening meals is recommended. The daily dosing times should be consistent.
SHR-1701 + Rivoceranib
Drug
Drug: SHR-1701 Administered by intravenous (IV) infusion on Day 1 of each 21-day cycle. The infusion time should be controlled between 30 and 60 minutes, and must not exceed 2 hours. Drug: Rivoceranib Administered orally (PO) once daily (QD), continuously. Administration Instructions: To be taken orally with warm water, approximately 30 minutes after a meal. The daily dosing time should be consistent.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: SHR-1701+Rivoceranib + SHR-2554Experimental treatment 1 intervention

Group B: SHR-1701 + Rivoceranib.Active comparator 1 intervention

Trial outcomes

Primary outcomes

Progression-free survival (PFS)

To evaluate the efficacy of anti-tumor by Resist1.1 (In months)

Time frame

From the date of first treatment until the date of first documented disease progression (assessed per RECIST 1.1) or death from any cause, whichever occurs first, assessed up to 24 months.

Secondary outcomes

Objective response rate (ORR)

To evaluate the efficacy of anti-tumor by Resist1.1

Time frame

From the start of treatment until the first occurrence of documented complete response (CR) or partial response (PR) per RECIST 1.1, assessed up to 24 month

Disease control rate (DCR)

To evaluate the efficacy of anti-tumor by Resist 1.1 (In percent)

Time frame

From the start of treatment until the first documented complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1, assessed up to 24 months.

Overall survival (OS)

To evaluate the efficacy of anti-tumor by Resist 1.1 (In months)

Time frame

From the date of first treatment until the date of death from any cause, assessed up to 36 months

Safety

Incidence and severity of treatment-emergent adverse events (TEAEs).

Time frame

From the first dose of study treatment until 30 days after the last dose, assessed up to approximately 26 months.

Other outcomes

Multi-omics analysis of the tumor microenvironment

ctDNA, TMB, etc.

Time frame

From enrollment to the end of the study

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jingdong Zhang

Lead sponsor

China Medical University, China

Sponsor institution

Source ClinicalTrials.gov

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