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NCT04643041: BASKET
Watch and Wait in PD-1 Monoclonal Antibody Treated dMMR/MSI-H Distal Rectal Cancer
NA trial testing watch and wait in Rectal Cancer in 47 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 47 |
| Start date | 1 January 2021 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- watch and wait
Conditions studied
- Rectal Cancer — all drugs for Rectal Cancer →
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Who can join
Adults 18 to 80, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Immunotherapy has achieved significant therapeutic effect in DNA mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-H) colorectal cancer (CRC) , more than fifty percent of dMMR/MSI-H CRC patients might get pathological complete response(pCR) after PD-1 monoclonal antibody treatment. For distant rectal cancer(RC), radical resection and neoadjuvant chemotherapy or chemoradiotherapy might cause lots of treatment cost,damage to defecation and sexual function, acute toxicity, chronic dysfunction, even loss of anus and psychological disorder. This study aims to evaluate the effect and safety of watch and wait in patients with dMMR/MSI-H distal RC accessed pCR after PD-1 monoclonal antibody therapy.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
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 -
Emerging Trends for Radio-Immunotherapy in Rectal Cancer.
Corrò C, Dutoit V, Koessler T. · · 2021 · cited 24× · PMID 33803620 · DOI 10.3390/cancers13061374 -
Clinical trials of neoadjuvant immune checkpoint inhibitors for early-stage operable colon and rectal cancer.
Veen T, Kanani A, Lea D, Søreide K. · · 2023 · cited 21× · PMID 37528319 · DOI 10.1007/s00262-023-03480-w -
Immunotherapy in the neoadjuvant treatment of gastrointestinal tumors: is the time ripe?
Gervaso L, Ciardiello D, Oliveira RA, Borghesani M, et al · · 2024 · cited 12× · PMID 38782539 · DOI 10.1136/jitc-2023-008027 -
Clinical status and future prospects of neoadjuvant immunotherapy for localized mismatch repair-deficient cancers: a review.
Li J. · · 2024 · cited 3× · PMID 38768473 · DOI 10.1097/js9.0000000000001680 -
Biology and evolving management of resectable dMMR/MSI-H cancers: current status and future perspectives.
Tanegashima T, Shiota M, Toyosaki K, Funakoshi K, et al · · 2025 · cited 1× · PMID 41196394 · DOI 10.1007/s00262-025-04223-9
Verify or expand the search:
- PubMed search for NCT04643041
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Rectal Cancer
Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04643041 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sixth Affiliated Hospital, Sun Yat-sen University
- Last refreshed: 12 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04643041.
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