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- || AiRuiYi (fluzoparib) / Jiangsu Hengrui Pharma
New P2 trial: Phase II Study of Irinotecan Liposome (II) Combined With Temozolomide and Fluzoparib in Recurrent or Metastatic Ewing Sarcoma (clinicaltrials.gov) - Feb 15, 2025
P2, N=29, Not yet recruiting, Sponsor: Sun Yat-sen University
- ||| irinotecan hydrochloride liposome injection (HR070803) / Jiangsu Hengrui Pharma
Clinical, P3 data, Journal, Combination therapy, Metastases: Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial. (Pubmed Central) - Sep 21, 2024
P3
No treatment-related deaths occurred in the HR070803 group, while the placebo group reported one treatment-related death (abdominal infection). HR070803 in combination with 5-FU/LV has shown promising efficacy and manageable safety in advanced or metastatic PDAC in the second-line setting, representing a potential option in this patient population.
- || irinotecan hydrochloride liposome injection (HR070803) / Jiangsu Hengrui Pharma, Onivyde (nanoliposomal irinotecan) / Servier, Ipsen
P1 data, Journal, Combination therapy, Metastases: Liposomal irinotecan (HR070803) in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors: a phase 1b dose-escalation and expansion study. (Pubmed Central) - Jul 22, 2024
P1
Retrospectively registered on Oct. 12, 2021.
- ||||| irinotecan hydrochloride liposome injection (HR070803) / Jiangsu Hengrui Pharma
Enrollment change: HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov) - May 8, 2024
P3, N=778, Recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
12, 2021. N=522 --> 778
- | Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, irinotecan hydrochloride liposome injection (HR070803) / Jiangsu Hengrui Pharma, Onivyde (nanoliposomal irinotecan) / Ipsen
New P2 trial: HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer (clinicaltrials.gov) - Apr 25, 2024
P2, N=120, Not yet recruiting, Sponsor: The First Affiliated Hospital with Nanjing Medical University
- | irinotecan hydrochloride liposome injection (HR070803) / Jiangsu Hengrui Pharma
New P3 trial: HR070803-307: HR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer (clinicaltrials.gov) - Jan 22, 2024
P3, N=524, Not yet recruiting, Sponsor: Fudan University
- |||||| irinotecan hydrochloride liposome injection (HR070803) / Jiangsu Hengrui Pharma
Enrollment open: A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer (clinicaltrials.gov) - Aug 24, 2023
P2/3, N=606, Recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
N=522 --> 778 Not yet recruiting --> Recruiting
- |||||||||| irinotecan hydrochloride liposome injection (HR070803) / Jiangsu Hengrui Pharma
New P2/3 trial: A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer (clinicaltrials.gov) - Jul 14, 2023
P2/3, N=606, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
- |||||| irinotecan hydrochloride liposome injection (HR070803) / Jiangsu Hengrui Pharma
Enrollment open: HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov) - Jun 29, 2023
P3, N=522, Recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || Erbitux (cetuximab) / Eli Lilly, EMD Serono, AiRuiKa (camrelizumab) / Jiangsu Hengrui Pharma
P2 data, Journal, Metastases: Cetuximab retreatment plus camrelizumab and liposomal irinotecan in patients with RAS wild-type metastatic colorectal cancer: Cohort B of the phase II CRACK study. (Pubmed Central) - May 10, 2023
No grade ?4 TRAEs were found in the safety population. Our study suggests that anti-EGFR retreatment therapy with cetuximab plus camrelizumab and liposomal irinotecan (HR070803) is a promising late-line treatment option with good antitumor activity and well-tolerated toxicity in RASwt mCRC patients.
- |||||||||| irinotecan hydrochloride liposome injection (HR070803) / Jiangsu Hengrui Pharma
New P3 trial: HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov) - Mar 2, 2023
P3, N=522, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
- |||| 5-fluorouracil / Generic mfg., HR070803 / Jiangsu Hengrui Pharma
Clinical: 🔥Phs-III with liposomal Irinotecan in 2nd line #PDAC presented at @ESMO22 LB61 🔥 ✅ HR070803+5-FU/LVs vs 5-FU/LV, 298 Chinese pts 👉combo: ORR 12.8% mPFS 4.21 mo mOS mOS of 7.4 mo-> OK 🧐in line with NAPOLI-1... @myESMO @OncoAlert (Twitter) - Sep 10, 2022
- || irinotecan hydrochloride liposome injection (HR070803) / Jiangsu Hengrui Pharma
Enrollment open: A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer (clinicaltrials.gov) - Sep 6, 2022
P2, N=30, Recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Our study suggests that anti-EGFR retreatment therapy with cetuximab plus camrelizumab and liposomal irinotecan (HR070803) is a promising late-line treatment option with good antitumor activity and well-tolerated toxicity in RASwt mCRC patients. Not yet recruiting --> Recruiting
- HR070803 / Jiangsu Hengrui Pharma
HR070803 plus 5-FU/LV versus placebo plus 5-FU/LV in second-line therapy for gemcitabine-refractory locally advanced or metastatic pancreatic cancer: A multicentered, randomized, double-blind, parallel-controlled phase III trial (HR-IRI-APC) (7.3.T - Toulouse Auditorium) - Jul 25, 2022 - Abstract #ESMO2022ESMO_1675;
P3
The incidence of all grade and grade≥3 diarrhea was 45.58% and 4.08%, neutropenia was 33.33% and 12.93%, cholinergic syndrome was 1.36% and 0% in arm A. Conclusions HR070803 plus 5-FU/LV demonstrated a highly statistically significant and clinically meaningful improvement in OS in treatment of locally advanced or metastatic PC with prior gemcitabine-based therapy. Along with a manageable safety profile, these data suggest HR070803 plus 5-FU/LV is a new treatment selection for the population.
- || irinotecan hydrochloride liposome injection (HR070803) / Jiangsu Hengrui Pharma
New P2 trial: A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer (clinicaltrials.gov) - Jun 21, 2022
P2, N=30, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.