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

NCT04278222 | Recruiting Phase 2

• 1 other identifier: APICAL-GC
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer; Immunotherapy; Anlotinib; Toripalimab

Outcome Measures

Primary Outcomes (1)

• objective response rate

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

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

Secondary Outcomes (5)

• Progress Free Survival

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

• Overall Survival

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

• Deepness of response

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

• Disease control rate

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

• adverse events

  Through study completion, an average of 4 weeks

Study Arms (1)

Anlotinib Plus Toripalimab

EXPERIMENTAL

the combination of Anlotinib Plus Toripalimab as first-line treatment

Drug: Anlotinib Plus Toripalimab

Interventions

Anlotinib Plus Toripalimab DRUG

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

Anlotinib Plus Toripalimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ECOG performance status 2;
• the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN), ALT and AST \<2.5 × ULN and if liver metastases, BIL \< 3 × ULN, ALT and AST \<5 × ULN; Serum Cr ≤ 1.5 × ULN;
• Patient's written declaration of consent obtained;
• Estimated life expectancy \> 3 months;

You may not qualify if:

• 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 ;
• with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ;
• severe wounds or surgery 4 weeks before recruitment;
• received glucocorticoid (more than 10mg prednisone ) and immunosuppressive agents;
• pregnancy or breast feeding;
• absent or restricted legal capacity;
• a significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Department of Medical Oncology, Shanghai Changzheng Hospital

Shanghai, China

RECRUITING

Related Publications (1)

• Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

  PMID: 35623069 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

anlotinib; toripalimab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 20, 2020
• Study Start: February 10, 2020
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

CN (1)