NCT04715633

PD-1 Inhibitors Combined With VEGF Inhibitors for Locally Advanced dMMR/MSI-H Colorectal Cancer

Active, enrolled Phase 2 Last updated 9 July 2024

What this trial tests

Phase 2 trial testing PD-1 inhibitor plus VEGF inhibitors in Colorectal Cancer in 53 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 December 2020

Primary endpoint
30 August 2023

31 July 2025

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	1 December 2020
Primary completion	30 August 2023
Estimated completion	31 July 2025
Sites	1 location across China

Drugs / interventions tested

• PD-1 inhibitor plus VEGF inhibitors — full drug profile →

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Microsatellite Instability High — all drugs for Microsatellite Instability High →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Colorectal Cancer or Microsatellite Instability High. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 inhibitors (Camrelizumab) plus VEGF inhibitor (Apatinib) for dMMR/MSI-H colorectal cancer staged as locally advanced (cT3-4N+/-M0 for rectal cancer, cT4 or cT3 with extramural extension ≥5mm for colon cancer). Radiological evaluation will be preformed after 4 cycles of treatment. Patients (either with colon or rectal cancer) who achieve complete clinical response will be offered the choice of Watch \& Wait.

Publications & conference data

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

1. Warburg effect in colorectal cancer: the emerging roles in tumor microenvironment and therapeutic implications.
   Zhong X, He X, Wang Y, Hu Z, et al · · 2022 · cited 223× · PMID 36319992 · DOI 10.1186/s13045-022-01358-5
2. Immunosuppressive tumor microenvironment modulation by chemotherapies and targeted therapies to enhance immunotherapy effectiveness.
   Barnestein R, Galland L, Kalfeist L, Ghiringhelli F, et al · · 2022 · cited 66× · PMID 36117524 · DOI 10.1080/2162402x.2022.2120676
3. Intratumor heterogeneity: the hidden barrier to immunotherapy against MSI tumors from the perspective of IFN-γ signaling and tumor-infiltrating lymphocytes.
   Wu W, Liu Y, Zeng S, Han Y, et al · · 2021 · cited 62× · PMID 34620200 · DOI 10.1186/s13045-021-01166-3
4. Microsatellite Instability in Colorectal Cancers: Carcinogenesis, Neo-Antigens, Immuno-Resistance and Emerging Therapies.
   Randrian V, Evrard C, Tougeron D. · · 2021 · cited 51× · PMID 34205397 · DOI 10.3390/cancers13123063
5. Unraveling Resistance to Immunotherapy in MSI-High Colorectal Cancer.
   Heregger R, Huemer F, Steiner M, Gonzalez-Martinez A, et al · · 2023 · cited 32× · PMID 37894457 · DOI 10.3390/cancers15205090
6. Microsatellite Instability: From the Implementation of the Detection to a Prognostic and Predictive Role in Cancers.
   Amato M, Franco R, Facchini G, Addeo R, et al · · 2022 · cited 32× · PMID 35955855 · DOI 10.3390/ijms23158726
7. Progress in the Application of Immune Checkpoint Inhibitor-Based Immunotherapy for Targeting Different Types of Colorectal Cancer.
   He R, Lao Y, Yu W, Zhang X, et al · · 2021 · cited 31× · PMID 34888243 · DOI 10.3389/fonc.2021.764618
8. Neoadjuvant camrelizumab plus apatinib for locally advanced microsatellite instability-high or mismatch repair-deficient colorectal cancer (NEOCAP): a single-arm, open-label, phase 2 study.
   Yu JH, Xiao BY, Li DD, Jiang W, et al · · 2024 · cited 23× · PMID 38852601 · DOI 10.1016/s1470-2045(24)00203-1