NCT03989310

An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic Pancreatic Cancer

Status unknown Phase 1, PHASE2 Last updated 23 December 2020

What this trial tests

Phase 1, PHASE2 trial testing Manganese Chloride in Pancreatic Cancer in 50 participants. Status unknown.

Timeline

1 March 2019

Primary endpoint
31 May 2021

31 March 2022

Quick facts

Lead sponsor	Chinese PLA General Hospital
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 March 2019
Primary completion	31 May 2021
Estimated completion	31 March 2022
Sites	1 location across China

Drugs / interventions tested

• Manganese Chloride (MANGANESE CHLORIDE) — full drug profile →
• nab-paclitaxel (nab-paclitaxel) — full drug profile →
• Gemcitabine (gemcitabine) — full drug profile →
• anti-PD-1 antibody — full drug profile →

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Chinese PLA General Hospital

Who can join

Adults 18 to 80, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The outcome of pancreatic cancer is extremely poor. NCCN guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen, but the response rate is unacceptably low. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This one-arm, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and chemotherapy.

Publications & conference data

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

1. Type I interferon-mediated tumor immunity and its role in immunotherapy.
   Yu R, Zhu B, Chen D. · · 2022 · cited 229× · PMID 35292881 · DOI 10.1007/s00018-022-04219-z
2. Tumor microenvironment in chemoresistance, metastasis and immunotherapy of pancreatic cancer.
   Wang S, Li Y, Xing C, Ding C, et al · · 2020 · cited 89× · PMID 32774994
3. Immunotherapy in Pancreatic Cancer: Why Do We Keep Failing? A Focus on Tumor Immune Microenvironment, Predictive Biomarkers and Treatment Outcomes.
   Di Federico A, Mosca M, Pagani R, Carloni R, et al · · 2022 · cited 82× · PMID 35626033 · DOI 10.3390/cancers14102429
4. Combination therapy for pancreatic cancer: anti-PD-(L)1-based strategy.
   Liu L, Huang X, Shi F, Song J, et al · · 2022 · cited 60× · PMID 35139879 · DOI 10.1186/s13046-022-02273-w
5. Therapeutic advances in metastatic pancreatic cancer: a focus on targeted therapies.
   Turpin A, Neuzillet C, Colle E, Dusetti N, et al · · 2022 · cited 20× · PMID 36090800 · DOI 10.1177/17588359221118019
6. Immunotherapy and Pancreatic Cancer: A Lost Challenge?
   Laface C, Memeo R, Maselli FM, Santoro AN, et al · · 2023 · cited 18× · PMID 37511856 · DOI 10.3390/life13071482
7. Therapeutic Application of Monoclonal Antibodies in Pancreatic Cancer: Advances, Challenges and Future Opportunities.
   Arias-Pinilla GA, Modjtahedi H. · · 2021 · cited 18× · PMID 33917882 · DOI 10.3390/cancers13081781
8. At the Crossroads of the cGAS-cGAMP-STING Pathway and the DNA Damage Response: Implications for Cancer Progression and Treatment.
   Korneenko TV, Pestov NB, Nevzorov IA, Daks AA, et al · · 2023 · cited 11× · PMID 38139802 · DOI 10.3390/ph16121675