In short
Clinical trials investigating Levoleucovorin are studying how it is used in cancer treatment combinations, mainly for digestive system cancers. These trials look at outcomes such as survival, disease control, and surgery results. The target groups include people with pancreatic, colon, rectal, gastric, gastroesophageal junction, and small bowel cancers.
Key points
- Clinical trials investigating Levoleucovorin are mainly studying cancer treatment combinations, especially for digestive system cancers. The source data includes Phase 2, Phase 3, and one Phase 4 study. Target populations include people with pancreatic, colon, rectal, small bowel, gastric, gastroesophageal junction, and metastatic cancers, as well as some groups defined by surgery status or tumor features. The main goals are to measure survival, disease control, recurrence, and the chance of curative surgery. Most studies use Levoleucovorin as part of a combination treatment rather than as a single treatment. One completed study is also listed in the data.
Clinical trial overview
The source data shows that Levoleucovorin is being studied in cancer trials as part of combination treatment plans. These studies are focused on whether the treatment plans help people live longer, keep the cancer under control, or improve the chance of successful surgery.
Most of the trials are interventional studies, which means the researchers give a treatment and then measure the results. The trials in the data include authorised studies and one completed study.
Cancer types being studied
Levoleucovorin is being studied in several cancers of the digestive system. These include pancreatic ductal adenocarcinoma, colon cancer, rectal cancer, small bowel adenocarcinoma, gastric cancer, and gastroesophageal junction cancer.
Some studies focus on cancer after surgery, such as resected pancreatic adenocarcinoma and stage III colon cancer after resection. Other studies include locally advanced disease, recurrent disease, or metastatic disease, which means the cancer is harder to treat because it is more spread out or has returned.
Trial phases and study sizes
The studies in the data are mainly Phase 2 and Phase 3, with one Phase 4 study. Phase 2 studies usually look more closely at whether a treatment seems helpful, while Phase 3 studies compare treatment strategies in larger groups.
Enrollment ranges from small studies with 30 patients to larger studies with 973 patients. This shows that the research includes both smaller focused studies and larger confirmatory trials.
What the trials measure
The main endpoints, or results the researchers want to measure, include overall survival (OS), progression-free survival (PFS), disease-free survival (DFS), and relapse-free survival (RFS). These terms describe how long patients live, how long the cancer does not worsen, or how long it stays away after treatment.
Some trials also measure surgery-related outcomes, such as the rate of R0 resection, which means surgery removes all visible cancer. One study looks at peritoneal metastasis-free survival, which is the time before cancer spreads to the lining of the abdomen.
Other studies use shorter-term measures, such as being alive and free of progression at a set time point like 85 days or 6 months. One trial also measures treatment tolerability, including acute digestive non-toxicity after radiotherapy, which means side effects affecting the digestive system are being checked closely.
Who may be included
The included patient groups are different from trial to trial. Some trials are for people after surgery, some are for people with cancer that has returned, and some are for people with metastatic disease.
Some studies have extra entry rules, such as HLA-A2 positive status, HER2-negative disease, or FGFR2b overexpression. These are tumor or patient features used to decide who can join a specific study.
One study focuses on patients aged 70 and older after stage III colon or upper rectal cancer resection. Another study includes patients with obstructive colon cancer who first had a stoma, which is a surgically created opening to help stool leave the body.
Examples of study designs
In one Phase 2 pancreatic cancer study, researchers are comparing maintenance treatment with OSE2101 plus FOLFIRI against FOLFIRI alone after induction therapy without disease progression. The main outcome is overall survival at 12 months.
In a Phase 3 rectal cancer study, researchers are testing chemotherapy followed by pelvic reirradiation against chemotherapy alone before surgery, and the main endpoint is the proportion of curative surgery. In a Phase 3 colon cancer study for older adults, the main endpoint is relapse-free survival at 3 years after surgery.
In a Phase 2 metastatic pancreatic cancer study, the trial is testing a first-line treatment plan that includes NALIRIFOX followed by 5-FU/leucovorin maintenance, and a second step that adds ciprofloxacin to gemcitabine-based chemotherapy. The trial measures 6-month progression-free survival in the first step and 6-month overall survival in the second step.
In a completed Phase 2 gastric and gastroesophageal junction cancer study, Levoleucovorin appears in a perioperative treatment plan with FLOT and bemarituzumab, and the study measured complete pathological response after surgery.