Health TrialsbyHealthPanel

A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer

ConditionGastric Cancer, Metastatic
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina Medical University, China

About this trial

This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, age≥ 18 years；

Patients with a diagnosis of gastric cancer by histopathology or cytology, accompanied by peritoneal metastasis, without systemic therapy, or for patients who have received neoadjuvant/adjuvant chemotherapy before, the time from last treatment to disease recurrence > 6 months;

Tumor Her2 negative (IHC 0/1＋ or IHC 2＋ and FISH-).

At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors （RECIST) 1.1;

Disqualifiers

History of other malignancies (except cured basal cell skin cancer, cervical carcinoma in situ etc.) within 5 years before study drug administration;

Patients with central nervous system metastases with clinical symptoms;

Patients who have been treated with high-dose systemic corticosteroids (prednisone > 10 mg/day or equivalent doses) or other immunosuppressants within 2 weeks before the first dose of BioTTT001;

Previous treatment with other adenovirus drugs within 28 days before the first dose of BioTTT001;

Trial design

Design model

Single group

Treatments tested in this trial

  • BioTTT001 intraperitoneal infusion

    Biological/Vaccine

    Monotherapy lead-in phase: BioTTT01 1×10\^10 VP, i.p., D1 and D3; Combination therapy phase: BioTTT01 1×10\^10 VP, i.p., D1 and D3, 3 weeks per cycle

  • SOX regimen

    Drug

    Combination therapy phase: Oxaliplatin 130 mg，i.v., D1 and D3, 3 weeks per cycle; Tegafur 40\~60mg b.i.d. p.o. D1\~D14; 3 weeks per cycle

  • toripalimab

    Drug

    Combination therapy phase: toripalimab 160mg i.v. D1, 3 weeks per cycle.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Combination therapy with BioTTT001 intraperitoneal infusion , SOX and ToripalimabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Objective response rate (ORR) as assessed by the investigators

Time frame
Imaging was performed every 6 weeks during the combination therapy phase

Secondary outcomes

1

Progression-free survival (PFS)

The time from the start of treatment to progress disease or death for any cause

Time frame
Every 6 weeks until disease progression, consent withdraw, death or end of study during the combination therapy phase, up to 100 weeks.
2

Overall survival (OS)

The time from the start of treatment to death for any cause

Time frame
Every 3 months until consent withdraw, death, withdrawal study, or loss of follow-up, up to 100 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

China Medical University, China

Lead sponsor

Beijing Bio-Targeting Therapeutics Technology Co., Ltd

Collaborator

Source ClinicalTrials.gov

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