Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer...
Metastatic Colorectal CancerThis is a two arm, 2-center, Phase II, study of 5-FU, irinotecan, bevacizumab (FOLFIRI-beva) and hydroxychloroquine (HCQ) in patients with previously untreated metastatic colorectal cancer (mCRC). Up to 155 patients will be screened for DTP-signature and up to 31 evaluable patients who are determined to be DTP-signature high will be treated with FOLFIRI-beva and HCQ. Patients will continue to receive treatments until evidence of disease progression, intolerable side effects, withdrawal of consent or death.
Fruquintinib Combined With Tislelizumab and HAIC in Patients With Advanced Colorectal Liver Metastases...
Colorectal CancerThis is a single-center, single-arm, open-label clinical study, to explore the efficacy and safety of fruquintinib combined with tislelizumab and HAIC (hepatic arterial infusion chemotherapy) in patients with colorectal liver metastases cancer (CRLM) who failed standard therapy.
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors
Colorectal CancerThe purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. Study details include: Study Duration per participant: Approximately 4 months M9140 is not available through an expanded access program
mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or IIIC Colorectal...
Colorectal CancerThis study will focus on postoperative patients of stage IIIB or stage IIIC colorectal cancer. These patients will start to accept chemotherapy in 3-4 weeks after operation, these patients were randomly divided into two groups, one group will accept adjuvant chemotherapy of mFOLFOX6 or CapeOX; another group will use mFOLFOXIRI, they can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. The efficacy and safety of adjuvant chemotherapy will be compared between the two groups. Disease-free survival, overall survival, incidence of adverse reaction of chemotherapy and postoperative quality of life will be recorded.
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab...
Metastatic Colorectal CancerThe purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: is metastatic (spread to other parts of the body); has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR) has a certain type of abnormal gene called "BRAF" and; has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
NKG2D CAR-NK Cell Therapy in Patients With Refractory Metastatic Colorectal Cancer
Refractory Metastatic Colorectal CancerNKG2D CAR-NK Cell Therapy in Patients With Refractory Metastatic Colorectal Cancer
D,L-MEthadone and mFOLFOX6 in Treatment of Advanced Colorectal Cancer
Chemo-refractory Colorectal CarcinomaThis is a phase I/II-trial with D,L-methadone and mFOLFOX6 in the treatment of patients with histologically confirmed chemo-refractory colorectal carcinoma. The aim of the phase-I trial is to evaluate the toxicity-profile and the dose-limiting toxicity of D,L-methadone combined with mFOLFOX6. Furthermore, to estimate the maximum tolerated dose and the recommended dose for phase-II-trial in the treatment of patients with histologically confirmed colorectal carcinoma not amenable to or progressing while having received all standard therapies. The primary endpoint of the randomized phase-II study is to determine the disease control rate 12 weeks after randomization of patients with histologically confirmed advanced colorectal carcinoma upon treatment with D,L methadone plus mFOLFOX6 versus mFOLFOX6 alone. Overall response rate according to RECIST1.1, progression free survival (PFS), overall survival (OS), quality of life (QoL) according to the EORTC QLQc30 questionnaire, patient-reported outcomes and safety will be evaluated as secondary objectives.
Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis...
Gynecologic CancerGynecologic Neoplasms8 moreBackground: Tumors that have spread to the lining of the abdomen from other cancers, such as cancer of the appendix, colon, or ovary, are called peritoneal carcinomatosis. In most cases, outcomes are poor. Researchers want to test a new treatment. Objective: To learn if the combination of oral nilotinib plus paclitaxel given by IV and directly into the abdomen can reduce tumors enough for people to have surgery. Eligibility: Adults aged 18 and older with peritoneal carcinomatosis that is too widespread for surgery. Design: Participants will be screened with: Physical exam Medical history Blood and urine tests Electrocardiogram Laparoscopy. They will get general anesthesia. Small cuts will be made in their abdomen. Tissue and fluid samples will be taken. Surveys about their health CT scans of their torso Participants will have up to 4 more laparoscopies. During the first procedure, a port will be placed under the skin of their abdomen (an IP port). It will be attached to a catheter that is placed in their abdomen. Participants will get treatment in 3-week cycles, for 3 or 6 cycles. They will take nilotinib by mouth twice daily. They will get paclitaxel by IP port (once per cycle) and by IV (twice per cycle). After cycles 3 and 6, they will have a laparoscopy and CT scans. Then they may take nilotinib and get IV paclitaxel for up to 1 year. At study visits, participants will repeat some screening tests. About 6 weeks after treatment ends and then every 3 months for 3 years, participants will have follow-up visits at NIH or with their local doctor....
Tislelizumab Plus Cetuximab and Irinotecan vs Third-line Standard-of-care in Refractory mCRC
Colorectal Neoplasms MalignantThis is a multicenter, randomized, controlled, phase II study to evaluate the efficacy and safety of tislelizumab combined with cetuximab and irinotecan(group A) compared to third-line regimens selected by researchers(group B) in the treatment of Ras wild-type recurrent and refractory metastatic colorectal cancer. This study will include Ras wild-type colorectal cancer that failed at least second-line treatment inthe past, including chemotherapy (oxaliplatin, irinotecan, fluorouracil) with or without targeted drugs (cetuximab, bevacizumab). 87 patients will be randomly assigned to group A and group B according to 2:1. The enrollment time is expected to be 12 months and the follow-up is expected to be 24 months.
BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma
Metastatic Colorectal CarcinomaNeuropathyThe study will assess the safety and efficacy of BXQ-350 plus modified FOLFOX7 (mFOLFOX7) and bevacizumab in participants who have newly diagnosed metastatic adenocarcinoma of the colon/rectum. The study will also evaluate if the administration of BXQ-350 with mFOLFOX7 and bevacizumab may diminish oxaliplatin induced sensory neurotoxicity, enabling participants to receive the total and planned doses of mFOLFOX7. All participants will receive BXQ-350 by intravenous (IV) infusion along with standard of care doses of mFOLFOX and bevacizumab. The study is divided into two stages: Stage 1 will be open label and will enroll participants at increasing dose levels of BXQ-350 in order to determine the Stage 2 dose. Stage 2 will be blinded; participants will receive BXQ-350 at the established Stage 1 dose or placebo.