Stephen Chan, MD Principal Investigator Department of Clinical Oncology, Chinese University of Hong Kong Lorenza Rimassa, MD Principal Investigator Humanitas Cancer Centre, IRCCS Humanitas Research Hospital
Kontakt
AstraZeneca Clinical Study Information Center Kontakt: Phone: 1-877-240-9479 E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen
Studienlocations (3 von 49)
Research Site D-13353 Berlin (Berlin) GermanyRekrutierend» Google-MapsResearch Site 60488 Frankfurt (Hessen) GermanyRekrutierend» Google-MapsResearch Site 24105 Kiel (Schleswig-Holstein) GermanyRekrutierend» Google-Maps
Research Site 50937 Köln (Nordrhein-Westfalen) GermanyNoch nicht rekrutierend» Google-MapsResearch Site 39120 Magdeburg (Sachsen-Anhalt) GermanyNoch nicht rekrutierend» Google-MapsResearch Site 68167 Mannheim (Baden-Württemberg) GermanyNoch nicht rekrutierend» Google-MapsResearch Site 92093 La Jolla United StatesNoch nicht rekrutierend» Google-MapsResearch Site 71103 Shreveport United StatesRekrutierend» Google-MapsResearch Site 48202 Detroit United StatesRekrutierend» Google-MapsResearch Site 93000 Bobigny FranceRekrutierend» Google-MapsResearch Site 92110 Clichy FranceRekrutierend» Google-MapsResearch Site 94010 Creteil FranceRekrutierend» Google-MapsResearch Site 69004 Lyon FranceRekrutierend» Google-MapsResearch Site 13005 Marseille FranceRekrutierend» Google-MapsResearch Site 35000 Rennes FranceRekrutierend» Google-MapsResearch Site 0000 Hong Kong Hong KongRekrutierend» Google-MapsResearch Site 00000 Shatin Hong KongRekrutierend» Google-MapsResearch Site 20132 Milano ItalyRekrutierend» Google-MapsResearch Site 80147 Napoli ItalyNoch nicht rekrutierend» Google-MapsResearch Site 35128 Padova ItalyRekrutierend» Google-MapsResearch Site 56126 Pisa ItalyRekrutierend» Google-MapsResearch Site 20089 Rozzano ItalyRekrutierend» Google-MapsResearch Site 10128 Turin ItalyRekrutierend» Google-MapsResearch Site 260-8677 Chiba-shi JapanRekrutierend» Google-MapsResearch Site 104-0045 Chuo-ku JapanZurückgezogen» Google-MapsResearch Site 920-8641 Kanazawa-shi JapanRekrutierend» Google-MapsResearch Site 277-8577 Kashiwa JapanRekrutierend» Google-MapsResearch Site 602-8566 Kyoto-shi JapanRekrutierend» Google-MapsResearch Site 790-0024 Matsuyama-city JapanRekrutierend» Google-MapsResearch Site 180-8610 Musashino-shi JapanRekrutierend» Google-MapsResearch Site 589-8511 Osakasayama-shi JapanRekrutierend» Google-MapsResearch Site 241-8515 Yokohama-shi JapanRekrutierend» Google-MapsResearch Site 13620 Gyeonggi-do Korea, Republic ofRekrutierend» Google-MapsResearch Site 13496 Seongnam-si Korea, Republic ofRekrutierend» Google-MapsResearch Site 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsResearch Site 03722 Seoul Korea, Republic ofRekrutierend» Google-MapsResearch Site 05505 Seoul Korea, Republic ofRekrutierend» Google-MapsResearch Site 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsResearch Site 119228 Singapore SingaporeRekrutierend» Google-MapsResearch Site 169610 Singapore SingaporeRekrutierend» Google-MapsResearch Site 308433 Singapore SingaporeRekrutierend» Google-MapsResearch Site 08036 Barcelona SpainRekrutierend» Google-MapsResearch Site 8035 Barcelona SpainRekrutierend» Google-MapsResearch Site 14004 Cordoba SpainRekrutierend» Google-MapsResearch Site 28007 Madrid SpainNoch nicht rekrutierend» Google-MapsResearch Site 28040 Madrid SpainRekrutierend» Google-MapsResearch Site 31008 Pamplona SpainRekrutierend» Google-MapsResearch Site 100000 Hanoi VietnamNoch nicht rekrutierend» Google-MapsResearch Site 700000 Ho Chi Minh VietnamNoch nicht rekrutierend» Google-Maps
1. Incidence of grade 3 or 4 possibly related to treatment adverse events (PRAEs) (Time Frame - From the date of first dose of IMP until 6 months after the initiation of study intervention): PRAE is defined as an AE which has been assessed by the investigator to be possibly related to IMP.
2. Objective response rate (ORR) (Time Frame - From the first dose of IMP until progression, or the last evaluable assessment in the absence of progression [approx. up to 33 months]): ORR is defined as the number (%) of participants with a confirmed objective tumour response (complete response [CR] or partial response [PR]) as determined by the investigator per Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1).
Secondary outcome:
1. Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESIs), immune-mediated AEs (imAEs) (Time Frame - From screening until 90 days following discontinuation of the last dose of IMP [approx. up to 33 months]): To assess the safety and tolerability of STRIDE in participants with advanced unresectable HCC
2. Overall Survival (OS) (Time Frame - From the date of the first dose of IMP until death [maximum follow-up approx. 33 months]): OS is defined as the time from the date of the first dose of IMP until death due to any cause.
3. Progression-Free Survival (PFS) (Time Frame - From the date of the first dose of IMP until the date of objective PD or death [maximum follow-up approx. 33 months]): PFS is defined as the time from the first dose of IMP until the date of objective PD (per RECIST 1.1 as assessed by the investigator) or death (by any cause in the absence of progression)
4. Disease Control Rate at Week 16 (DCR-16w) (Time Frame - At Week 16): DCR-16w is defined as the percentage of participants who have a best objective response of complete response or partial response (by Week 16 + 7 days) or who have stable disease for at least 16 weeks (-7 days), following the start of study intervention as determined by the investigator per RECIST 1.1
5. Disease Control Rate at Week 24 (DCR-24w) (Time Frame - At Week 24): DCR-24w is defined as the percentage of participants who have a best objective response of complete response or partial response (by Week 24 + 7 days) or who have stable disease for at least 24 weeks (-7 days), following the start of study intervention per RECIST 1.1
6. Duration of Response (DOR) (Time Frame - From the date of first documented response until the first date of documented progression or death in the absence of disease progression [approx. up to 33 months]): DOR is defined as the time from the date of first documented response until the date of documented progression per RECIST 1.1, as assessed by the investigator or death in the absence of disease progression.
7. Duration of Treatment (DOT) (Time Frame - From the date of first dose of IMP to the date of last dose of IMP [approx. up to 33 months]): DOT is defined as time on study intervention.
8. Time to deterioration in Health-Related Quality of Life (HRQoL), assessed using the EORTC QLQ C-30. (Time Frame - Every 8 weeks from date of first dose of IMP for the first 48 weeks and then every 12 weeks thereafter until treatment discontinuation and 90 days after last dose during safety follow-up [approx. up to 33 months]): Time to deterioration is defined as time from date of first dose of study intervention to the date of the first clinically meaningful deterioration (defined as a a decrease from baseline of at least 10 points for EORTC QLQ-C30 global HRQoL and functional scales, and an increase from baseline of at least 10 points for the EORTC QLQ-C30 symptom scales) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration. The domains/scales of the EORTC QLQ-C30 prioritized include global health status/QoL, functioning (physical), multi-term symptom (fatigue) and single item symptoms (appetite loss and nausea). Final scores range from 0 to 100, where higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales represent greater symptom severity.
9. Clinically meaningful change from baseline in HRQoL as assessed by EORTC QLQ C-30 (Time Frame - Every 8 weeks from date of first dose of IMP for the first 48 weeks and then every 12 weeks thereafter until treatment discontinuation and 90 days after last dose during safety follow-up [approx. up to 33 months]): Clinically meaningful change from baseline in global health status/QoL, symptoms and function score (categorized as improvement, no change or deterioration) is defined as an absolute change in the score from baseline of ≥ 10 for scales from the EORTC QLQ-C30 to assess disease and treatment related symptoms and HRQoL.The domains/scales of the EORTC QLQ-C30 prioritized include global health status/QoL, functioning (physical), multi-term symptom (fatigue) and single item symptoms (appetite loss and nausea). Final scores range from 0 to 100, where higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales represent greater symptom severity.
10. Best overall response for HRQoL as assessed by EORTC QLQ C-30 (Time Frame - Every 8 weeks from date of first dose of IMP for the first 48 weeks and then every 12 weeks thereafter until treatment discontinuation and 90 days after last dose during safety follow-up [approx. up to 33 months]): Best overall response for global health status/QoL, function and symptom (fatigue) will be derived as the best response the participant achieved, based on evaluable electronic patient-reported outcome (ePRO) data collected during the study period to assess disease and treatment related symptoms and HRQoL. The domains/scales of the EORTC QLQ-C30 prioritized include global health status/QoL, functioning(physical), multi-term symptom (fatigue) and single item symptoms (appetite loss and nausea). Final scores range from 0 to 100, where higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales represent greater symptom severity.
11. Change from baseline in HRQoL as assessed by EORTC QLQ C-30 (Time Frame - Every 8 weeks from date of first dose of IMP for the first 48 weeks and then every 12 weeks thereafter until treatment discontinuation and 90 days after last dose during safety follow-up [approx. up to 33 months]): Change from baseline of global health status/QoL, symptom and functioning scores to assess disease and treatment related symptoms and HRQoL. The domains/scales of the EORTC QLQ-C30 prioritized include global health status/QoL, functioning(physical), multi-term symptom (fatigue) and single item symptoms(appetite loss and nausea). Final scores range from 0 to 100, where higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales represent greater symptom severity.
12. Time to deterioration in HRQoL as assessed by EORTC QLQ-HCC18 (Time Frame - Every 8 weeks from date of first dose of IMP for the first 48 weeks and then every 12 weeks thereafter until treatment discontinuation and 90 days after last dose during safety follow-up [approx. up to 33 months]): Time to deterioration is defined as time from date of first dose of study intervention to the date of the first clinically meaningful deterioration (defined as an increase from baseline of at least 10 points for EORTC QLQ-HCC18) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration. The QLQ-HCC18 is an HCC-specific module from the EORTC comprising 18 questions to assess HCC symptoms. The module includes 6 multi-item domain scales and 2 single-item scales. Final scores range from 0 to 100 where higher scores indicate a greater level of symptom severity and a poorer HRQoL. The items prioritized are single items shoulder pain, abdominal pain and abdominal swelling.
13. Clinically meaningful change from baseline in HRQoL as assessed by EORTC QLQ-HCC18 (Time Frame - Every 8 weeks from date of first dose of IMP for the first 48 weeks and then every 12 weeks thereafter until treatment discontinuation and 90 days after last dose during safety follow-up [approx. up to 33 months]): Clinically meaningful change from baseline (categorized as improvement, no change or deterioration) is defined as an absolute change in the score from baseline of ≥ 10 for scales/items from QLQ-HCC18 to assess disease-related symptoms. The single items prioritized are shoulder pain, abdominal pain and abdominal swelling. The EORTC QLQ-HCC18 module is an 18-item questionnaire. All questions have a 4-point scale: "Not at all," "A little," "Quite a bit," and "Very much." For each of the 8 domains (6 multiple-item scales and 2 single-item scales), final scores are transformed such that they range from 0 to 100, where higher scores indicate greater level of symptoms and worse symptom or a poorer HRQoL.
14. Best overall response for HRQoL as assessed by EORTC QLQ-HCC18 (Time Frame - Every 8 weeks from date of first dose of IMP for the first 48 weeks and then every 12 weeks thereafter until treatment discontinuation and 90 days after last dose during safety follow-up [approx. up to 33 months]): Best overall response in single-item symptoms (shoulder pain, abdominal pain, abdominal swelling) will be derived as the best response the participant achieved, based on evaluable ePRO data collected during the study period to assess disease-related symptoms. The single items prioritized are shoulder pain, abdominal pain and abdominal swelling. The EORTC QLQ-HCC18 module is an 18-item questionnaire. All questions have a 4-point scale: "Not at all," "A little," "Quite a bit," and "Very much." For each of the 8 domains (6 multiple-item scales and 2 single-item scales), final scores are transformed such that they range from 0 to 100, where higher scores indicate greater level of symptoms and worse symptom or a poorer HRQoL.
15. Change from baseline in HRQoL as assessed by EORTC QLQ-HCC18 (Time Frame - Every 8 weeks from date of first dose of IMP for the first 48 weeks and then every 12 weeks thereafter until treatment discontinuation and 90 days after last dose during safety follow-up [approx. up to 33 months]): Change from baseline assessment in EORTC QLQ-HCC18 scale/item score at each post baseline assessment. The prioritized single items scores are shoulder pain, abdominal pain and abdominal swelling. The EORTC QLQ-HCC18 module is an 18-item questionnaire. All questions have a 4-point scale: "Not at all," "A little," "Quite a bit," and "Very much." For each of the 8 domains (6 multiple-item scales and 2 single-item scales), final scores are transformed such that they range from 0 to 100, where higher scores indicate greater level of symptoms and worse symptom or a poorer HRQoL.