Global Analysis Shows Significant Variability in Sarcoma Clinical Trial Availability

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Disparate trends in the amount and phase of sarcoma clinical trials, as well as their sponsorship sources, were found in a global analysis presented during the 2025 ESMO Sarcoma and Rare Cancers Congress.1

“This idea came to me when I was in Milan a few months ago. When we were going through the clinical trials that were available on site, I saw that despite sarcomas being rare, there were quite a few trials available on site. In my country Armenia, there were no trials in sarcomas available, so I wanted to go back and see what the distribution [of studies was] worldwide,” Amalya Sargsyan, MD, MSc, lead study author and medical oncologist at the Yeolyan Hematology and Oncology Center, and research fellow at the Immune Oncology Research Institute, in Yerevan, Armenia, stated in a presentation of the data.

Investigators documented interventional clinical trials sourced from ClinicalTrials.gov using the terms sarcoma or soft tissue sarcoma. Only trials that were recruiting or not yet recruiting and in either phase 1/2, 2, 2/3, or 3 were included in the analysis. Additionally, the trials had to be initiated within the decade from January 1, 2015, to January 1, 2025.

A total of 258 ongoing interventional sarcoma trials were identified globally. Most trials were phase 2, with 150 trials (58%), followed by phase 1/2 with 82 trials (32%), phase 3 with 23 trials (9%), and phase 2/3 with 3 trials (1%). With respect to geographic distribution, the United States had the most trials at 92 and the highest percentage of early-phase research globally (42%), followed by China, Europe, North America and Asia, and North America and Europe.

“Not surprisingly, most of the trials—more than half—are in phase 2. If we compare that with the more common subtypes of cancer, like lung cancer, it will be mostly phase 3. However, [because] sarcoma is a rare cancer and regulatory [parameters are] different, most of the pivotal trials and regulatory approval trials are phase 2; it’s not surprising to see this picture,” Sargsyan said.

Western European countries were responsible for most trials in Europe, hosting 82% of studies vs 35% of Eastern European countries. Within Europe, France, Spain, and Italy were the most active in terms of trial activity, with 42, 25, and 23 trials, respectively.

“In Europe, the leading [countries] were France, Italy, and Spain,” Sargsyan said. “However, if we divide Europe, we saw that almost 85% of Western European countries had sarcoma clinical trials, while most countries in Eastern Europe did not have any available sarcoma trials.”

A total of 10 collaborative trials were identified between North America and Europe, and 7 between North America and Asia. Notably, Asia had the most efficient trial durations, averaging 1311 days for later-phase trials, which was much faster than the global average of 2320 days.

“China had the fastest recruitment time, with a median of [approximately] 1300 days, whereas the global median is [approximately] 2300 days,” Sargsyan said.

With respect to all-phase overall clinical trial durations, the fastest recruiters were North America and Europe, followed by North America and Asia, Europe, the United States, North and South America and Europe, South America, and China.

Investigators also determined that 62 trials were sponsored by industry, 17 of which were being conducted solely in the United States. Another 14 trials were global collaborations, and 10 were based in Asia.

“[Clinical trials] for common cancers are mostly industry funded, [but for sarcoma and rare cancers we see] mostly academic and investigator-initiated trials––only a quarter is funded by industry,” Sargsyan said.

Notably, 25% of phase 1/2 trials were sponsored by industry, 4% of phase 3 trials were sponsored by the National Institutes of Health, and 4% of phase 2/3 trials were sponsored by a network. Only 1% of other trials were sponsored by another government agency, and most phase 2 trials were sponsored by another entity (66%).

“[We saw] that most of the Western and high-income countries are involved, while Africa is absent, and most parts of Asia, except China, are also absent. Some parts of Latin America were also involved [in clinical trials],” Sargsyan said. “So, what can we do? We could probably unite our forces [through our collaborative] networks,” Sargsyan concluded.

Disclosures: Sargsyan had no disclosures.

Reference

Sargsyan A, Harutyunyan M, Baloyan E, Bardakhchyan S. Global trends in ongoing sarcoma clinical trials: disparities and efficiencies. ESMO Open. 2025;10(suppl 3):104373. doi:10.1016/j.esmoop.2025.104373