Health TrialsbyHealthPanel

Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)

ConditionsGastric CancerImmunotherapyAnlotinibToripalimab
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Changzheng Hospital

About this trial

This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed, UICC stage IV gastric cancer;

no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy;

at least one measurable lesion;

received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using RECISET criteria;

Disqualifiers

harboring HER2 positive including IHC 3+ or IHC 2+ with Fish positive;

dMMR/MSI-H;

Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification);

have received anlotinib or other immune checkpoint inhibitor ;

Trial design

Design model

Single group

Treatments tested in this trial

  • Anlotinib Plus Toripalimab

    Drug

    Anlotinib 12mg oral administration daily d1-d14, q3w; Toripalimab 240mg iv drop d1, q3w

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Anlotinib Plus ToripalimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

objective response rate

Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

Time frame
Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks

Secondary outcomes

1

Progress Free Survival

Time from treatment beginning until disease progression

Time frame
Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 8 weeks
2

Overall Survival

Time from treatment beginning until death from any cause

Time frame
From date of treatment beginning until the date of death from any cause, through study completion, an average of 8 weeks
3

Deepness of response

Investigation of depth of response during first-line treatment

Time frame
Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks
4

Disease control rate

Proportion of patients with reduction and non-change in tumor burden of a predefined amount, including complete remission, partial remission and stable disease

Time frame
Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks

Other outcomes

Sponsors and contacts

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

Shanghai Changzheng Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now