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Envafolimab plus lenvatinib and capecitabine shows activity in resected biliary tract cancerCombination therapy shows promise for preventing biliary tract cancer recurrence after surgery

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Key Takeaway
Interpret early DFS/OS signals from this small single-arm adjuvant BTC study with caution pending RCT validation.

This prospective, single-center, single-arm phase II trial evaluated the efficacy and safety of subcutaneous envafolimab (400 mg every 3 weeks) combined with oral lenvatinib (8 mg daily) and capecitabine (1000 mg/m² twice daily, 2 weeks on/1 week off) as adjuvant therapy. The study enrolled 28 patients with biliary tract cancer (BTC) who had undergone R0 resection and were considered at high risk for recurrence.

After a median follow-up of 12.0 months, the primary outcome of median disease-free survival (DFS) was 15.63 months. The 1-year DFS rate was 68.3%. For overall survival (OS), the median was not reached, and the 1-year OS rate was 91.4%. No effect sizes, p-values, or confidence intervals were reported for these outcomes.

Regarding safety, treatment-related adverse events (TRAEs) occurred in 17 patients, with grade 3/4 TRAEs observed in eight patients. The study reported a manageable safety profile. The number of treatment discontinuations was not reported. Key limitations include the single-arm design, single-center setting, and small sample size, which preclude definitive efficacy conclusions and limit generalizability. The authors note these findings require validation in larger, multicenter, randomized controlled trials. The funding source and author conflicts of interest were not reported.

Researchers conducted a small, early-stage study to test whether a combination of three drugs could help prevent cancer from returning after surgery for biliary tract cancer. The study involved 28 patients who had their cancer surgically removed but were at high risk of it coming back. Patients received three medications: envafolimab (given as a shot every three weeks), lenvatinib (taken as a daily pill), and capecitabine (taken as pills on a specific schedule).

After about a year of follow-up, researchers found that the median time patients lived without their cancer returning was about 15.6 months. About 68% of patients were cancer-free at one year, and about 91% were still alive at one year. The treatment had side effects, with 17 patients experiencing treatment-related issues and 8 having more serious side effects, but overall the safety profile was considered manageable.

It's important to understand this was a phase II study, which means it's still in early testing. The study didn't have a comparison group receiving standard treatment or placebo, so we can't say for sure if this combination works better than existing approaches. The study was also small and conducted at just one medical center, which limits how broadly we can apply these results.

While these early results are encouraging for patients with this challenging cancer, much more research is needed. Larger studies with comparison groups will be necessary to determine if this three-drug combination should become a standard treatment option after surgery for biliary tract cancer.

What this means for you:
Early study shows promising results for preventing cancer recurrence, but larger trials are needed to confirm.

Study Details

Study typePhase2
Sample sizen = 17
EvidenceLevel 3
Follow-up12.0 mo
PublishedApr 2026
View Original Abstract ↓
BACKGROUND: Biliary tract cancer (BTC) is an aggressive malignancy characterized by a high recurrence rate and poor postoperative prognosis, despite advances in adjuvant therapy. This phase II study evaluated the efficacy and safety of a novel adjuvant regimen combining envafolimab, lenvatinib, and capecitabine in patients with BTC at high risk of recurrence following R0 resection. METHODS: This single-center, open-label, single-arm phase II trial enrolled patients with high-risk recurrence factors after curative resection. Patients received envafolimab (400 mg subcutaneously once every 3 weeks), Lenvatinib (8 mg orally once daily), and capecitabine (1000 mg/m orally twice daily, 2 weeks on/1 week off, continued without cycle limitation). The primary endpoint was disease-free survival (DFS); secondary endpoints included overall survival (OS) and safety. RESULTS: 28 of 30 screened patients were included in the final analysis. The median DFS was 15.63 months, and the 1-year DFS rate was 68.3%. Median OS was not reached but 1-year OS was 91.4%. Treatment-related adverse events (TRAEs) occurred in 17 patients, with grade 3/4 TRAEs observed in eight patients. No treatment-related deaths were reported. Exploratory analysis suggested that baseline CA19-9 levels were significantly associated with early recurrence. CONCLUSIONS: The adjuvant combination of envafolimab, lenvatinib, and capecitabine demonstrates promising efficacy and a manageable safety profile in high-risk BTC patients after R0 resection. However, these findings still require validation in larger, multicenter, randomized controlled trials.
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