Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-13
Brief Title:
A Phase lblI Clinical Study in Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Sponsor:
Rui-hua Xu MD PhD
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Fruquintinib Combined With AK104 and Tegafur Gimeracial and Oteracil as Second-ine or After Line Treatment in Advanced or Metastatic ESCC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single-arm open-labelmulti-center phase IbII study aiming to evaluate the efficacy and safety of Fruquintinib combined With Cadonilimab AK104 and TegafurGimeracil and Oteracil Potassium in patients with locally advanced or metastatic esophageal squamous cell carcinoma after the failure of first-line treatments
Detailed Description:
Esophageal cancer is a malignant tumor with high incidence and death rate in the world especially in china and Esophageal squamous cell carcinoma ESCC is the main pathological type of esophageal carcinoma in China Among patients with advanced or metastatic esophageal squamous cell carcinoma the addition of immunotherapy to chemotherapy compared with chemotherapy significantly improved overall survival and progression-free survival in first-line treatments Treatment of recurrent or metastatic esophageal squamous cell carcinoma is usually poor New treatments were neededFruquintinib is an orally antiangiogenic agents which target VEGFR123 Candonilimab AK104 is a PD-1CTLA-4 Bispecific Antibody A combination of Fruquintinib and Candonilimab AK104 and s-1 for advanced or metastatic esophageal squamous cell carcinoma could be a novel therapy Therefore investigators initialize this phase IbII study to explore the efficacy and safety of fruquintinib in combination with Candonilimab AK104 and S-1 treatment in ESCC patients with after failure in 1st-line treatment
In dose escalation period 3-12 patients with Esophageal squamous cell carcinoma will be enrolled Patients meeting enrollment eligibility will receive 21-day cycles of fruquintinib 2-3 mg qdD1-14Q3W combined with Candonilimab 10 mgkgD1Q3W and S-1 30mg BID for body surface area 125 m240mg BID for body surface area 125 - 15 m250mg BID for body surface area 15m2 D1-14Q3W
Safety information will be collected till disease progression or intolerable toxicity to determine MTD andor RPTD of fruquintinib combined with Candonilimab and S-1 in patients with Esophageal squamous cell carcinoma
This period will include the following 2 dose groups from low to high
A Fruquintinib 2 mg qd for 2 weeks followed by 1-week break Candonilimab 10 mgkgintravenous infusionD1 every 3 weeks S-1 Calculate dosage based on body surface 30mg for BSA 125 m240 mg for BSA 125 - 15 m2 50mg for BSA 15m2BIDD1-14Q3W
B Fruquintinib 3 mg qd for 2 weeks followed by 1-week break Candonilimab 10 mgkgintravenous infusionD1 every 3 weeks S-1 Calculate dosage based on body surface 30mg for BSA 125 m240 mg for BSA 125 - 15 m2 50mg for BSA 15m2BIDD1-14Q3W
This study will use traditional 33 trial design 3 subjects will be enrolled in each dose group first
If 1 case of DLT is observed additional 3 subjects will be enrolled in the same dose groupwhen no new DLTs occurred the trial was continued to the next dose level to further evaluate toxicity to observe DLT and evaluate MTD
If there are 2 or more cases of DLT in one dose group the group lower than this dose group by one level is MTD dose group If 2 dose group levels MTD was not reached then the B group dose was RP2DDLT was predefined by the investigator in the protocol
Subjects in the original dose group will continue to receive the next cycle of treatment at the original dose till disease progression or treatment withdrawal due to any of the following reasons 1 death 2 intolerable toxicity 3 pregnancy 4 the investigator considers the study should be terminated for the subjects best interests 5 the subject or legal representative requests withdrawal 6 loss to follow-up 7 the subject has poor compliance and cannot comply with the study protocol
In phase II periodpatients meeting enrollment eligibility will receive Fruquintinib PR2D in combination with Candonilimab 10 mgkgintravenous infusionD1 every 3 weeks and S-1 Calculate dosage based on body surface 30mg for BSA 125 m240 mg for BSA 125 - 15 m2 50mg for BSA 15m2BIDD1-14Q3W till disease progression or treatment withdrawal due to any of the following reasons 1 death 2 intolerable toxicity 3 pregnancy 4 the investigator considers the study should be terminated for the subjects best interests 5 the subject or legal representative requests withdrawal 6 loss to follow-up 7 the subject has poor compliance and cannot comply with the study protocol
In dose escalation period 3-12 patients with Esophageal squamous cell carcinoma will be enrolled Patients meeting enrollment eligibility will receive 21-day cycles of fruquintinib 2-3 mg qdD1-14Q3W combined with Candonilimab 10 mgkgD1Q3W and S-1 30mg BID for body surface area 125 m240mg BID for body surface area 125 - 15 m250mg BID for body surface area 15m2 D1-14Q3W
Safety information will be collected till disease progression or intolerable toxicity to determine MTD andor RPTD of fruquintinib combined with Candonilimab and S-1 in patients with Esophageal squamous cell carcinoma
This period will include the following 2 dose groups from low to high
A Fruquintinib 2 mg qd for 2 weeks followed by 1-week break Candonilimab 10 mgkgintravenous infusionD1 every 3 weeks S-1 Calculate dosage based on body surface 30mg for BSA 125 m240 mg for BSA 125 - 15 m2 50mg for BSA 15m2BIDD1-14Q3W
B Fruquintinib 3 mg qd for 2 weeks followed by 1-week break Candonilimab 10 mgkgintravenous infusionD1 every 3 weeks S-1 Calculate dosage based on body surface 30mg for BSA 125 m240 mg for BSA 125 - 15 m2 50mg for BSA 15m2BIDD1-14Q3W
This study will use traditional 33 trial design 3 subjects will be enrolled in each dose group first
If 1 case of DLT is observed additional 3 subjects will be enrolled in the same dose groupwhen no new DLTs occurred the trial was continued to the next dose level to further evaluate toxicity to observe DLT and evaluate MTD
If there are 2 or more cases of DLT in one dose group the group lower than this dose group by one level is MTD dose group If 2 dose group levels MTD was not reached then the B group dose was RP2DDLT was predefined by the investigator in the protocol
Subjects in the original dose group will continue to receive the next cycle of treatment at the original dose till disease progression or treatment withdrawal due to any of the following reasons 1 death 2 intolerable toxicity 3 pregnancy 4 the investigator considers the study should be terminated for the subjects best interests 5 the subject or legal representative requests withdrawal 6 loss to follow-up 7 the subject has poor compliance and cannot comply with the study protocol
In phase II periodpatients meeting enrollment eligibility will receive Fruquintinib PR2D in combination with Candonilimab 10 mgkgintravenous infusionD1 every 3 weeks and S-1 Calculate dosage based on body surface 30mg for BSA 125 m240 mg for BSA 125 - 15 m2 50mg for BSA 15m2BIDD1-14Q3W till disease progression or treatment withdrawal due to any of the following reasons 1 death 2 intolerable toxicity 3 pregnancy 4 the investigator considers the study should be terminated for the subjects best interests 5 the subject or legal representative requests withdrawal 6 loss to follow-up 7 the subject has poor compliance and cannot comply with the study protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None