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Poster Display session

153P - Preliminary activity of camrelizumab plus gemcitabine and oxaliplatin in the transformation of unresectable gallbladder cancer: A single arm, phase II, prospective clinical study

Date

07 Dec 2024

Session

Poster Display session

Presenters

Rui Zhang

Citation

Annals of Oncology (2024) 35 (suppl_4): S1450-S1504. 10.1016/annonc/annonc1688

Authors

R. Zhang, W. Deng, Q. Liu, C. Liu

Author affiliations

  • Department Of Biliary-pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, 510288 - Guangzhou, China/CN

Resources

This content is available to ESMO members and event participants.

Abstract 153P

Background

Less than 20% of patients(pts) with gallbladder carcinoma (GBCs) are eligible for surgery at the time of diagnosis. Nowadays, systemic therapy holds great promise for downstaging or even converting unresectable tumors to resectable tumors. Previous studies have shown that the conversion rate of unresectable GBCs is less than 17% only with chemotherpy. This study intends to provide a thorough analysis of the efficacy and safety of Camrelizumab in combination with gemcitabine plus oxaliplatin (GEMOX) as conversion therapy for patients (pts) diagnosed with unresectable GBCs*.

Methods

The study is an ongoing single-arm, phase II trial. A total of 37 pts diagnosed with unresectable GBCs pathologically and radiologically are expected to be enrolled. Pts enrolled will receive Camrelizumab (200mg iv. d1, q3w) combined with gemcitabine (800-1000mg/kg iv. d1, q3w) plus oxaliplatin (80-100mg/kg iv. d1, q3w) (Trial registration number: NCT05919095). Treatment is maintained for 4-8 sessions until disease progression or intolerable toxicity. The primary endpoint is radical tumor resection rate.

Results

At the data cutoff (July 2024), the median follow-up was 8.43 months(95%CI:7.23-9.63months), 8 pts had been enrolled and accepted the Camrelizumab plus GEMOX. Among them, 8 pts with hilar lymph node metastasis, 2 pts with invasion of the pancreas, 1 pts with invasion of duodenum, 4 pts with invasion portal vein or hepatic artery. After a median of 4(2-6) treatment cycles, 7 patients achieved partial response. Successful conversion rate based on radiology was 75% (6/8), of which 5 (62.5%) pts underwent R0 resection and 2 (25%) pts were waiting further surgical intervention. All patients survived without any signs of tumor recurrence. No patients had grade ≥3 treatment-related adverse events (TRAEs). For the patients who received successful conversion, the median survival time after surgery was 4.43 months (95% CI: 3.99–5.14 months).

Conclusions

Camrelizumab combined with GEMOX may be a favorable conversion therapy in unresectable GBCs patients. However, sufficient patients need to be enrolled to further evaluate the efficacy and safety of the conversion therapy.

Clinical trial identification

NCT06423170.

Editorial acknowledgement

Xiao-qiang Fang (Jiangsu Hengrui Pharmaceuticals Co., Ltd.) provided editorial assistance in the writing of the abstract.

Legal entity responsible for the study

Sun Yat-sen Memorial Hospital, Sun Yat-sen University.

Funding

Jiangsu Hengrui Pharmaceuticals Co, Ltd.

Disclosure

All authors have declared no conflicts of interest.

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