Health TrialsbyHealthPanel

Conversion Therapy With Retlirafusp Alfa Plus Chemotherapy in Gastric or Gastroesophageal Junction Adenocarcinoma

ConditionsGastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital

About this trial

This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa plus CAPOX as conversion therapy in patients with potentially resectable gastric or gastroesophageal junction adenocarcinoma. Eligible participants will receive preoperative retlirafusp alfa in combination with capecitabine and oxaliplatin. Patients who achieve complete response or partial response and are considered suitable for R0 resection after multidisciplinary team assessment will undergo radical surgery. The primary outcome is R0 resection rate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed gastric or gastroesophageal junction adenocarcinoma by gastroscopic biopsy.

Potentially resectable gastric or gastroesophageal junction adenocarcinoma as judged by the investigator, including but not limited to: T4b disease or fixed/fused lymph nodes; single liver metastasis, limited para-aortic lymph node metastasis (No.16a2/b1), or CY1P0 disease; more than one liver metastasis or a liver metastasis larger than 5 cm adjacent to the hepatic vein or portal vein, extensive para-aortic lymph node metastasis (No.16a1/b2), or selected distant metastases such as Virchow lymph node or lung metastasis.

HER2-low, HER2-intermediate, or HER2-negative disease, and PD-L1 CPS ≥1.

Age 18 to 75 years.

Disqualifiers

History of malignancy within 5 years or current presence of another malignancy.

Prior systemic therapy for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Macroscopically visible peritoneal metastasis or other unresectable distant metastasis.

Active bleeding from the tumor as shown by endoscopy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Retlirafusp Alfa

    Drug

    Retlirafusp alfa 1800 mg will be administered by intravenous infusion on Day 1 of each 21-day cycle. When administered with chemotherapy, retlirafusp alfa will be given first, followed by chemotherapy after an interval of at least 30 minutes.

  • Oxaliplatin

    Drug

    Oxaliplatin 130 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.

  • Capecitabine

    Drug

    Capecitabine 1000 mg/m\^2 will be administered orally twice daily on Days 1-14 of each 21-day cycle. Interventi

  • Radical Surgery

    Procedure/Surgery

    Participants who achieve complete response or partial response and are considered suitable for R0 resection after multidisciplinary team assessment will undergo radical surgery 4 to 6 weeks after the last dose of preoperative treatment.

Treatment groups

21 Participants
are divided into 1 treatment group
Group A: Retlirafusp Alfa Plus CAPOXExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

R0 Resection Rate

The proportion of enrolled participants who undergo radical surgery with microscopically margin-negative resection. R0 resection will be assessed based on postoperative pathological evaluation.

Time frame
From treatment initiation to pathological assessment after radical surgery, up to approximately 28 weeks

Secondary outcomes

1

Conversion Surgery Rate

The proportion of enrolled participants who undergo radical surgery after preoperative conversion therapy and multidisciplinary team assessment.

Time frame
From treatment initiation to radical surgery, up to approximately 24 weeks
2

Event-Free Survival

Event-free survival is defined as the time from initiation of treatment to the first occurrence of radiographic disease progression according to RECIST version 1.1, tumor recurrence confirmed by imaging or biopsy, or death from any cause, whichever occurs first.

Time frame
From treatment initiation to disease progression, recurrence, or death from any cause, assessed up to approximately 32 months
3

Objective Response Rate

Objective response rate is defined as the proportion of participants who achieve complete response or partial response according to RECIST version 1.1.

Time frame
From baseline to preoperative tumor assessment after completion of preoperative conversion therapy, up to approximately 20 weeks
4

Overall Survival

Overall survival is defined as the time from treatment initiation to death from any cause.

Time frame
From treatment initiation to death from any cause, assessed up to approximately 32 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Tang-Du Hospital

Lead sponsor

Source ClinicalTrials.gov

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