NCT04318730

Phase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma

Recruiting now Phase 2 Last updated 17 July 2024

What this trial tests

Phase 2 trial testing Camrelizumab in Adrenocortical Carcinoma in 21 participants. Currently enrolling.

Timeline

1 October 2020

Primary endpoint
1 December 2023

1 April 2025

Quick facts

Lead sponsor	West China Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	1 October 2020
Primary completion	1 December 2023
Estimated completion	1 April 2025
Sites	1 location across China

Drugs / interventions tested

• Camrelizumab — full drug profile →

Conditions studied

• Adrenocortical Carcinoma — all drugs for Adrenocortical Carcinoma →

Sponsor

West China Hospital

Who can join

18 and older, any sex, with Adrenocortical Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Adrenocortical carcinoma (ACC) is a rare aggressive malignant tumor. According to the literature, the 5-year survival rate of ACC is 12%-47%. For patients with advanced ACC, mitotane alone or combined with traditional chemotherapy was the first-line standard treatment, but its progression-free survival was only about 1 year. However, for patients who fail the first-line treatment, there is a lack of effective treatment. For ACC patients who had failed first-line chemotherapy, a phase II clinical trial found that the objective response rate and the disease control rate of PD-1 inhibitor Keytruda were 14% and 64% respectively, and no grade 3 or 4 adverse events were observed. Anti-tumor angiogenic drugs combined with PD-1 inhibitors have shown impressive clinical data in many solid tumors. This study is aimed to evaluate the efficacy and safety of PD-1 inhibitor camrelizumab combined with apatinib in patients with recurrent or metastatic ACC after standard treatment failure, and to seek new treatment for this population.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tumor Microenvironment in Adrenocortical Carcinoma: Barrier to Immunotherapy Success?
   Georgantzoglou N, Kokkali S, Tsourouflis G, Theocharis S. · · 2021 · cited 21× · PMID 33918733 · DOI 10.3390/cancers13081798
2. The Immunotherapy Landscape in Adrenocortical Cancer.
   Pegna GJ, Roper N, Kaplan RN, Bergsland E, et al · · 2021 · cited 18× · PMID 34071333 · DOI 10.3390/cancers13112660
3. Microsatellite instability and chemosensitivity in solid tumours.
   Cherri S, Oneda E, Noventa S, Melocchi L, et al · · 2022 · cited 13× · PMID 35620236 · DOI 10.1177/17588359221099347
4. The Efficacy and Safety of Immune Checkpoint Inhibitors in Adrenocortical Carcinoma: A Systematic Review and Meta-Analysis.
   Ababneh O, Ghazou A, Alawajneh M, Alhaj Mohammad S, et al · · 2024 · cited 12× · PMID 38473262 · DOI 10.3390/cancers16050900
5. Adrenocortical Carcinomas: Molecular Pathogenesis, Treatment Options, and Emerging Immunotherapy and Targeted Therapy Approaches.
   Chukkalore D, MacDougall K, Master V, Bilen MA, et al · · 2024 · cited 11× · PMID 38381694 · DOI 10.1093/oncolo/oyae029
6. Camrelizumab plus apatinib for previously treated advanced adrenocortical carcinoma: a single-arm phase 2 trial.
   Zhu YC, Wei ZG, Wang JJ, Pei YY, et al · · 2024 · cited 9× · PMID 39609453 · DOI 10.1038/s41467-024-54661-9
7. Angiogenesis in the Normal Adrenal Fetal Cortex and Adrenocortical Tumors.
   Pereira SS, Oliveira S, Monteiro MP, Pignatelli D, et al · · 2021 · cited 9× · PMID 33804534 · DOI 10.3390/cancers13051030
8. Targeted Therapy for Adrenocortical Carcinoma: A Genomic-Based Search for Available and Emerging Options.
   Hescheler DA, Hartmann MJM, Riemann B, Michel M, et al · · 2022 · cited 5× · PMID 35681700 · DOI 10.3390/cancers14112721