- |||||||||| Keytruda (pembrolizumab) / Merck (MSD)
Biomarker, Trial completion date, Trial primary completion date, Metastases: Pembrolizumab Plus Chemotherapy in 1st Line Treatment of Pancreatic Cancer (clinicaltrials.gov) - Apr 18, 2024 P2, N=77, Active, not recruiting, Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD)
Trial completion, Trial completion date, Surgery, Metastases: Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery (clinicaltrials.gov) - Apr 18, 2024 P1/2, N=31, Completed, N=110 --> 71 Active, not recruiting --> Completed | Trial completion date: May 2024 --> Oct 2023
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD)
Phase classification, Surgery, Metastases: Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery (clinicaltrials.gov) - Apr 17, 2024 P1/2, N=31, Active, not recruiting, Recruiting --> Active, not recruiting | N=134 --> 56 | Trial primary completion date: Jan 2025 --> Apr 2024 Phase classification: P1b/2 --> P1/2
- |||||||||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Journal: Desulfovibrio desulfuricans and its derived metabolites confer resistance to FOLFOX through METTL3. (Pubmed Central) - Apr 15, 2024 A high abundance of Desulfovibrio in the intestines indicates poor therapeutic outcomes for postoperative neoadjuvant FOLFOX chemotherapy in CRC. Desulfovibrio drives the manifestation of METTL3 in CRC, promoting resistance to FOLFOX chemotherapy by increasing the concentration of SAM.
- |||||||||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Accelerating Evidence Generation and Time to Insight With Clinical AI () - Apr 14, 2024 - Abstract #ISPOR2024ISPOR_2510; To be useful for evidence generation, clinical AI must be able to reason over real-world data with physician-like intelligence. This session will: Explore how to evaluate clinical-specific reasoning capacity in AI & suitability for clinical applications Share data on how clinical AI-enabled analytics compare to unassisted analytics Delve into AI explainability and controlling hallucinations
- |||||||||| Tecentriq (atezolizumab) / Roche
P1/2 data, Journal: Chemotherapy Plus Atezolizumab Pre- and Post-Resection in Localized Esophageal or Gastroesophageal Junction Adenocarcinomas: A Phase I/II Single-Arm Study. (Pubmed Central) - Apr 13, 2024 P2 This single-center phase I/II trial evaluated the safety, toxicity, and efficacy of neoadjuvant atezolizumab with oxaliplatin and 5-fluorouracil (modified FOLFOX) followed by esophagectomy followed by atezolizumab...Although modified FOLFOX plus atezolizumab did not achieve the expected pathCR, an acceptable safety profile was observed. Our results support the continued development of a more refined strategy (neoadjuvant chemotherapy plus perioperative immunotherapy/targeted agents) with molecular/immune profiling in parallel.
- |||||||||| Avastin (bevacizumab) / Roche
Biomarker, Trial completion date, Trial primary completion date: Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer (clinicaltrials.gov) - Apr 11, 2024 P3, N=3610, Active, not recruiting, Active, not recruiting --> Completed | Trial completion date: Aug 2026 --> Nov 2023 Trial completion date: Mar 2024 --> Sep 2024 | Trial primary completion date: Mar 2024 --> Sep 2024
- |||||||||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
Preoperative common hepatic artery embolization for pancreatic tail surgery () - Apr 10, 2024 - Abstract #ECIO2024ECIO_540; Colonoscopy was performed with biopsy of adenocarcinoma and it was decided to perform colostomy and start treatment with FOLFIRINOX (6 cycles)...3).Pre-surgical vascular embolization is a valuable tool to establish collaterals to maintain the flow in organs which will not be resected. Vascular occluders are an excellent tool, and can be complemented with other embolizing agents.
- |||||||||| albumin-bound paclitaxel / Generic mfg.
Minimally invasive intratumoral holmium-166 microsphere implantation in patients with pancreatic ductal adenocarcinoma () - Apr 10, 2024 - Abstract #ECIO2024ECIO_517; P=N/A Primary endpoints are feasibility, assessed by post-procedural SPECT, and safety, assessed by continuous adverse event monitoring (CTCAE v5.0). For exploratory endpoints, ECOG score, Quality of Life questionnaires (EQ-5D-5L, EORTC QLQ-C30), pain scales, and laboratory examination focused on pancreatic, liver, immune, and renal function are performed at baseline and at every outpatient visit, and tumor response is assessed by RECIST after 16 weeks.
- |||||||||| Enlituo (cetuximab biosimilar) / Mabpharm Limited, Sorrento
Trial completion date, Metastases: CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer (clinicaltrials.gov) - Apr 10, 2024 P3, N=520, Active, not recruiting, For exploratory endpoints, ECOG score, Quality of Life questionnaires (EQ-5D-5L, EORTC QLQ-C30), pain scales, and laboratory examination focused on pancreatic, liver, immune, and renal function are performed at baseline and at every outpatient visit, and tumor response is assessed by RECIST after 16 weeks. Trial completion date: Jun 2023 --> Jun 2024
- |||||||||| Opdivo (nivolumab) / BMS
Enrollment change, Trial completion date, Trial primary completion date: CA209-8TT: Pan Tumor Rollover Study (clinicaltrials.gov) - Apr 10, 2024 P2, N=1500, Recruiting, Trial completion date: Jun 2023 --> Jun 2024 N=800 --> 1500 | Trial completion date: Aug 2025 --> Aug 2029 | Trial primary completion date: Aug 2025 --> Aug 2029
- |||||||||| Journal, HEOR, BRCA Biomarker, PARP Biomarker, BRCA Companion diagnostic, PARP Companion diagnostic, Cost-effectiveness, Cost effectiveness, Metastases: Olaparib not cost-effective as maintenance therapy for platinum-sensitive, BRCA1/2 germline-mutated metastatic pancreatic cancer. (Pubmed Central) - Apr 8, 2024
Olaparib is not a cost-effective maintenance treatment option. Companion diagnostics are an equally important cost driver as the drug itself.
- |||||||||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., irinotecan / Generic mfg.
Journal, BRCA Biomarker, PARP Biomarker: A Somatic BRCA2-Mutated Pancreatic Adenocarcinoma With Sustained Exceptional Response to Modified FOLFIRINOX. (Pubmed Central) - Apr 8, 2024 Patients with HRR deficiency-associated gene mutations such as BRCA1, BRCA2, and PALB2 are more susceptible to platinum-based chemotherapies and in those with somatic BRCA mutations, PARP inhibitor therapy prolongs progression-free survival. The case discussed herein illustrates the therapeutic opportunities offered through the identification of HRR deficiency in pancreatic cancer, as well as the challenges associated with treatment and prevention of central nervous system metastases in long-term survivors of pancreatic cancer.
- |||||||||| Enrollment closed, Trial completion date, Trial primary completion date: PASS-01: Pancreatic Adenocarcinoma Signature Stratification for Treatment (clinicaltrials.gov) - Apr 8, 2024
P2, N=150, Active, not recruiting, Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> Sep 2026 | Trial primary completion date: Sep 2022 --> Jan 2025
- |||||||||| 5-fluorouracil / Generic mfg., oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg.
Enrollment closed, Trial primary completion date: NOM-ERA: Non-Operative Management and Early Response Assessment in Rectal Cancer (clinicaltrials.gov) - Apr 8, 2024 P=N/A, N=63, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2024 --> Sep 2024
- |||||||||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Trial suspension, Trial primary completion date: Organ Preservation in Early Rectal Cancer Patients (clinicaltrials.gov) - Apr 4, 2024 P2, N=19, Suspended, No abstract available Recruiting --> Suspended | Trial primary completion date: Mar 2024 --> Mar 2025
- |||||||||| Cynviloq (paclitaxel polymeric micelle formulation) / Sorrento, Samyang Group, ImmunityBio
Phase classification, Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date, Combination therapy, Metastases: QUILT-2.022 NANT-008 in Combination w/ 5-fluorouracil, Bevacizumab, Leucovorin & Oxaliplatin in Subjects With Pancreatic Cancer (clinicaltrials.gov) - Apr 4, 2024 P1/2, N=0, Withdrawn, Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2024 --> Apr 2025 Phase classification: P1b/2 --> P1/2 | N=64 --> 0 | Trial completion date: Dec 2024 --> Dec 2023 | Suspended --> Withdrawn | Trial primary completion date: Dec 2024 --> Dec 2023
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