Clinical trial · Interventional

The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSS Locally Advanced Rectal Cancer

A Phase II Trial of Immunotherapy Combined With Neoadjuvant Chemoradiotherapy in Microsatellite Stable Locally Advanced Rectal Cancer

NCT04411537CI-TRIAL-00045355unknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stable (MSS) locally advanced rectal cancer (LARC). A total of 50 MSS LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. The tumor response grade, adverse effects and long-term prognosis will be analyzed.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Locally Advanced Rectal Cancer	Malignant Rectal Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Capecitabine	Drug	Capecitabine	ALIAS
Irinotecan	Drug	Irinotecan	ALIAS
Neoadjuvant Radiotherapy	Radiation	—	UNRESOLVED
PD-1 antibody	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Treatment Arm
description
A total of 50 MSS LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX.
interventionNames
1. Drug: PD-1 antibody
2. Drug: Capecitabine
3. Drug: Irinotecan
4. Radiation: Neoadjuvant Radiotherapy

Primary outcomes (1)

measure
Pathologic Complete Response Rate
timeFrame
The pathologic complete response rate was evaluated after surgery, which was scheduled 7-8 weeks after the end of chemoradiotherapy
description
Pathologic Complete Response Rate

Secondary outcomes (8)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

1. pathological confirmed adenocarcinoma
2. clinical stage T3-4 and/or N+
3. the distance from anal verge less than 12 cm
4. without distance metastases
5. age 18-70 years old, female and male
6. KPS \>=70
7. UGT1A1\*28 6/6 or 6/7
8. the MSI status is MSS or p-MMR
9. without previous anti-cancer therapy or immunotherapy
10. with good compliance
11. signed the inform consent

Exclusion Criteria:

1. pregnancy or breast-feeding women
2. history of other malignancies within 5 years
3. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
4. immunodeficiency disease or long-term using of immunosuppressive agents
5. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
6. DPD deficiency
7. UGT1A1\*28 7/7
8. the MSI status is MSI-H or d-MMR
9. allergic to any component of the therapy

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jul 1, 2020
Primary completion: Apr 30, 2022
Completion: Dec 31, 2022
First posted: Jun 2, 2020
Last update posted: Jun 2, 2020
Enrollment: 50 (estimated)
Lead sponsor: Fudan University OTHER

Data updated 22 days agoSource updated Jun 2, 2020source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
China	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.