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Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Gastric or Gastroesophageal Junction Cancer

ConditionGastric Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenan Cancer Hospital

About this trial

This is a prospective, single-arm, investigator-initiated phase II clinical study. The study evaluates the efficacy and safety of retlirafusp alfa (a PD-L1/TGF-βRII bifunctional fusion protein) combined with apatinib (a VEGFR-2 tyrosine kinase inhibitor) and nab-paclitaxel in patients with locally advanced unresectable, locally recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma who have progressed after first-line immunotherapy-containing treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to provide written informed consent prior to any study-specific procedures

Age ≥ 18 years

ECOG performance status 0 or 1

Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced unresectable, locally recurrent, or metastatic

Disqualifiers

Known hypersensitivity to any component of the study drugs

Prior treatment with any VEGFR inhibitor (including apatinib, sorafenib, sunitinib)

Prior treatment with retlirafusp alf

Received any investigational drug within 4 weeks before first dose

Trial design

Design model

Single group

Treatments tested in this trial

  • Retlirafusp alfa + Apatinib + Nab-paclitaxel

    Drug

    Retlirafusp alfa: 1800 mg, intravenous infusion, day 1, every 3 weeks; until disease progression, unacceptable toxicity, or withdrawal; maximum 2 years Apatinib: 250 mg, oral, once daily; until disease progression, unacceptable toxicity, or withdrawal Nab-paclitaxel: 260 mg/m², intravenous infusion, day 1, every 3 weeks; for 4-6 cycles

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Retlirafusp alfa + Apatinib + Nab-paclitaxelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria, assessed every 6 weeks

Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled

Secondary outcomes

1

Disease Control Rate (DCR)

Proportion of patients achieving CR, PR, or stable disease (SD) per RECIST 1.1

Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
2

Progression-Free Survival (PFS)

Time from enrollment to disease progression or death from any cause

Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled
3

Overall Survival (OS)

Time from enrollment to death from any cause

Time frame
From date of enrollment until the date of death from any cause, assessed up to 12 months after the last subject enrolled
4

Duration of Response (DoR)

Time from first documented response to disease progression or death

Time frame
From first response to progression or death, up to 10 months after the last subject enrolled

Other outcomes

Sponsors and contacts

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

Henan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: