NCT04083365: PANDORA

Capecitabine Plus Concomitant Radiation Therapy Followed by Durvalumab as Preoperative Treatment in Rectal Cancer

Status unknown Phase 2 Last updated 31 May 2023

What this trial tests

Phase 2 trial testing Capecitabine in RECTAL CANCER in 100 participants. Status unknown.

Timeline

1 January 2020

Primary endpoint
30 November 2022

31 August 2025

Quick facts

Lead sponsor	AUSL Romagna Rimini
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 January 2020
Primary completion	30 November 2022
Estimated completion	31 August 2025
Sites	1 location across Italy

Drugs / interventions tested

• Capecitabine (capecitabine) — full drug profile →
• Radiotherapy — full drug profile →
• Durvalumab — full drug profile →

Conditions studied

• RECTAL CANCER — all drugs for RECTAL CANCER →

Sponsor

AUSL Romagna Rimini — full company profile →

Who can join

Adults 18 to 100, any sex, with RECTAL CANCER. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective phase II, open label, single arm, multi-centre study to evaluate activity of an innovative sequence on capecitabine plus concomitant radiation therapy followed by durvalumab in patients with operable rectal cancer. The enrollment period will be of 12 months. Eligible patients will be initiated to a standard concomitant chemoradiation therapy for 5 weeks. One week after the end of CT/RT patients will be treated with durvalumab for 3 administrations. Patient will undergo surgery after 10-12 weeks from the end of CT/RT and the surgical piece will be analyzed. After surgery patients will be followed up for 5 years, according to clinical practice.

Publications & conference data

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

1. IFNγ signaling integrity in colorectal cancer immunity and immunotherapy.
   Du W, Frankel TL, Green M, Zou W. · · 2022 · cited 112× · PMID 34385592 · DOI 10.1038/s41423-021-00735-3
2. Clinicopathological characteristics of high microsatellite instability/mismatch repair-deficient colorectal cancer: A narrative review.
   Mei WJ, Mi M, Qian J, Xiao N, et al · · 2022 · cited 41× · PMID 36618386 · DOI 10.3389/fimmu.2022.1019582
3. Neoadjuvant immunotherapy for colorectal cancer: Right regimens, right patients, right directions?
   Zhu J, Lian J, Xu B, Pang X, et al · · 2023 · cited 38× · PMID 36949951 · DOI 10.3389/fimmu.2023.1120684
4. Phase II study of capecitabine-based concomitant chemoradiation followed by durvalumab as a neoadjuvant strategy in locally advanced rectal cancer: the PANDORA trial.
   Grassi E, Zingaretti C, Petracci E, Corbelli J, et al · · 2023 · cited 30× · PMID 37774508 · DOI 10.1016/j.esmoop.2023.101824
5. Advances and new frontiers for immunotherapy in colorectal cancer: Setting the stage for neoadjuvant success?
   Sumransub N, Vantanasiri K, Prakash A, Lou E. · · 2021 · cited 25× · PMID 34307839 · DOI 10.1016/j.omto.2021.05.001
6. Emerging Trends for Radio-Immunotherapy in Rectal Cancer.
   Corrò C, Dutoit V, Koessler T. · · 2021 · cited 24× · PMID 33803620 · DOI 10.3390/cancers13061374
7. PD‑1/PD‑L1 immune checkpoint inhibitors in neoadjuvant therapy for solid tumors (Review).
   Tang Q, Zhao S, Zhou N, He J, et al · · 2023 · cited 19× · PMID 36866750 · DOI 10.3892/ijo.2023.5497
8. Challenges and exploration for immunotherapies targeting cold colorectal cancer.
   Li DD, Tang YL, Wang X. · · 2023 · cited 15× · PMID 36684057 · DOI 10.4251/wjgo.v15.i1.55